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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement obturator
510(k) Number K970779
Device Name OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
Applicant
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Applicant Contact KATE SUTTON
Correspondent
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Correspondent Contact KATE SUTTON
Regulation Number878.3300
Classification Product Code
LZN  
Subsequent Product Code
JWH  
Date Received03/04/1997
Decision Date 05/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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