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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, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K934857
Device Name HSS FEMORAL COMPONENTS
Applicant
Hospital For Special Surgery
535 E. 70 St.
New York,  NY  10021
Applicant Contact BRUCE H ROBIE, PH.D
Correspondent
Hospital For Special Surgery
535 E. 70 St.
New York,  NY  10021
Correspondent Contact BRUCE H ROBIE, PH.D
Regulation Number888.3350
Classification Product Code
JDI  
Date Received10/12/1993
Decision Date 07/18/1995
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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