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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, cement restrictor
510(k) Number K900462
Device Name OSTEONICS CEMENT RESTRICTOR
Original Applicant
OSTEONICS CORP.
59 route 17
allendale,  NJ  07401 -1677
Original Contact pat kramer
Regulation Number878.3300
Classification Product Code
JDK  
Date Received01/31/1990
Decision Date 03/06/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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