FDA 510(k) Application Details - K955473

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

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510(K) Number K955473
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact ANGIE IIDE
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 11/30/1995
Decision Date 02/16/1996
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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