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FDA 510(k) Application Details - K974044
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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510(K) Number
K974044
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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ARLENE C SAULL
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Regulation Number
888.3660
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Classification Product Code
KWS
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More FDA Info for this Product Code
Date Received
10/24/1997
Decision Date
01/22/1998
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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