FDA 510(k) Application Details - K993601

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

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510(K) Number K993601
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070-2584 US
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Contact NANCY J RIEDER
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Regulation Number 888.3360

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Classification Product Code LWJ
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Date Received 10/25/1999
Decision Date 11/16/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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