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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brace, Drill
510(k) Number K923776
Device Name BENDEREV DRILL GUIDE
Applicant
Neimark Labs, Inc.
26732 Crown Valley, 501
Mission Viejo,  CA  92691
Applicant Contact NEIL H NAVES
Correspondent
Neimark Labs, Inc.
26732 Crown Valley, 501
Mission Viejo,  CA  92691
Correspondent Contact NEIL H NAVES
Regulation Number888.4540
Classification Product Code
HXY  
Date Received07/28/1992
Decision Date 11/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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