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FDA 510(k) Application Details - K052748
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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510(K) Number
K052748
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH, NJ 07430 US
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Contact
KAREN ARIEMMA
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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
09/30/2005
Decision Date
12/02/2005
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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