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FDA 510(k) Application Details - K972792
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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510(K) Number
K972792
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070 US
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Contact
FRANK MAAS
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Regulation Number
888.3350
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Classification Product Code
JDI
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More FDA Info for this Product Code
Date Received
07/28/1997
Decision Date
10/16/1997
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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