FDA 510(k) Application Details - K972931

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

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510(K) Number K972931
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant HHL CONSULTING
835 CORTEZ LN.
FOSTER CITY, CA 94404 US
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Contact HARTMUT LOCH
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Regulation Number 888.3360

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Classification Product Code LWJ
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Date Received 08/08/1997
Decision Date 11/13/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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