FDA 510(k) Application Details - K955171

Device Classification Name Prosthesis, Hip, Femoral Component, Cemented, Metal

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510(K) Number K955171
Device Name Prosthesis, Hip, Femoral Component, Cemented, Metal
Applicant NEXMED, INC.
42-160 STATE ST.
PALM DESERT, CA 92211-5148 US
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Contact REBECCA H WAHL
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Regulation Number 888.3360

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Classification Product Code JDG
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Date Received 11/13/1995
Decision Date 02/09/1996
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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