FDA 510(k) Application Details - K960908

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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510(K) Number K960908
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant STELKAST COMPANY
800 VINIAL ST. #210
PITTSBURGH, PA 15212 US
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Contact DONALD A STEVENS
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Regulation Number 888.3360

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Classification Product Code LWJ
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Date Received 03/05/1996
Decision Date 08/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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