food and drug administration · additional information 510(k) original submission traditional...

137

Upload: others

Post on 23-Aug-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 2: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 3: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 4: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 5: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 6: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 7: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 8: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 9: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 10: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 11: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 12: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 13: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 14: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 15: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 16: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 17: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 18: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 19: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 20: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 21: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 22: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 23: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 24: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 25: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 26: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 27: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 28: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 29: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 30: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 31: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 32: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 33: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 34: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 35: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 36: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 37: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 38: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 39: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 40: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 41: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 42: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 43: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 44: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 45: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 46: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 47: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 48: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 49: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 50: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 51: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 52: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 53: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 54: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 55: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 56: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 57: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 58: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 59: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 60: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 61: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 62: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 63: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 64: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 65: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(4) Engineering Drawings

Page 66: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(4) Engineering Drawings

Page 67: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(4) Engineering Drawings

Page 68: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(4) Engineering Drawings

Page 69: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(4) Engineering Drawings

Page 70: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 71: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 72: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 73: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 74: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 75: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 76: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 77: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 78: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 79: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 80: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 81: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 82: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 83: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 84: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 85: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 86: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 87: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 88: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 89: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 90: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 91: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 92: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 93: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 94: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 95: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 96: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 97: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 98: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 99: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 100: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 101: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 102: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 103: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 104: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 105: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 106: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 107: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 108: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 109: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 110: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 111: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 112: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 113: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 114: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 115: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 116: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 117: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 118: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 119: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 120: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 121: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 122: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 123: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 124: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 125: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 126: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 127: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 128: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 129: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 130: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 131: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 132: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 133: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(4) Engineering Drawings

Page 134: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(

4) M

anuf

actu

ring

Info

rmat

ion

Page 135: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(

4) E

ngin

eerin

g D

raw

ings

Page 136: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party
Page 137: Food and Drug Administration · Additional Information 510(k) Original Submission Traditional SPecial Abbreviated (Complete section l, Page 5) a "Additional Information Third Party

(b)(

4) E

ngin

eerin

g D

raw

ings