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FDA 510(k) Application Details - K033634
Device Classification Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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510(K) Number
K033634
Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant
CENTERPULSE ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN, TX 78717 US
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Contact
AUDREY SWEARINGEN
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Regulation Number
888.3330
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Classification Product Code
KWA
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Date Received
11/19/2003
Decision Date
09/15/2004
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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