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FDA 510(k) Application Details - K032659
Device Classification Name
Prosthesis, Hip, Femoral, Resurfacing
More FDA Info for this Device
510(K) Number
K032659
Device Name
Prosthesis, Hip, Femoral, Resurfacing
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
Contact
Natalie Heck
Other 510(k) Applications for this Contact
Regulation Number
888.3400
More FDA Info for this Regulation Number
Classification Product Code
KXA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2003
Decision Date
12/04/2003
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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