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Page 1: Food and Drug AdministrationPMT Depth Electrode Anchor Bolt design 4-1 PMT@ Corporation Safety Considerations 510(k) Notification Anchor Bolt, Depthalon Electrode Accessory 27, 1997

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For DCRIVD Use OnIV

DGRAID Classification Checklist for Premarket Notification 5100c)

Device: "ýx'q 77-Submitter:

V-received-. Review 11ýateoriginal 510(k): This submission: cycle

Review 11-ter (circle one): 1, 11, 111

(for Tier 1, complete items 1-5 on the Screening Checkfisd

Question Yes No

A. Is the product a device? V

Is the device exempt from 510(k) by regulation or policy?

C. Expedited Review Status: Requested by sponsor

Identified by DCRND

Granted by DCRND

D. Has this device has been the subject of a previous NSE dectsion7

It yes, does this new 51 0(k) address the NSE Issues(s), e.g., performance data?

E. Has the sponsor been the subject of an integrity investigation?

If yes, has the ODE Integrity Officer given permission to proceed with the review?

-7 Administrative Reviewer Signature: Date:

Michael Pugfisi

Cddý'MGCA-Pfi(.-XS I 0k.Cr-A.( Apni 13, 1995 OCRNO fo- 102

) )

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(b)(4) Testing

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(b)(4) Testing

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