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FDA 510(k) Application Details - K023786
Device Classification Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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510(K) Number
K023786
Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact
KARLA A HAM
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Regulation Number
888.3330
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Classification Product Code
KWA
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Date Received
11/13/2002
Decision Date
12/10/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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