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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K970490
Device Name PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
Applicant
STELKAST COMPANY
800 VINIAL ST.
SUITE B-210
PITTSBURGH,  PA  15212
Applicant Contact DONALD A STEVENS
Correspondent
STELKAST COMPANY
800 VINIAL ST.
SUITE B-210
PITTSBURGH,  PA  15212
Correspondent Contact DONALD A STEVENS
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
JDI  
Date Received02/10/1997
Decision Date 05/02/1997
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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