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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, operating-room, pneumatic
510(k) Number K953961
Device Name OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM
Applicant
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Applicant Contact TERRY JAROSZ
Correspondent
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Correspondent Contact TERRY JAROSZ
Regulation Number878.4960
Classification Product Code
FWW  
Subsequent Product Codes
HWT   KKX   LXH  
Date Received08/22/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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