FDA 510(k) Application Details - K915594

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

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510(K) Number K915594
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant DEPUY, INC.
P.O. BOX 988
WARSAW, IN US
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Contact DAVID KOTKOVETZ
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 12/13/1991
Decision Date 04/14/1993
Decision SE - Substantially Equivalent
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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