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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, Hemi-, Femoral, Metal
510(k) Number K954534
Device Name OSTEONICS UNIPOLAR ENDO HEAD
Applicant
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact TERRT JAROSZ
Correspondent
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact TERRT JAROSZ
Regulation Number888.3360
Classification Product Code
KWL  
Date Received09/29/1995
Decision Date 11/30/1995
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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