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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral, Resurfacing
510(k) Number K032659
Device Name DEPUY ASR RESURFACING FEMORAL HEADS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact Natalie Heck
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact Natalie Heck
Regulation Number888.3400
Classification Product Code
KXA  
Date Received08/28/2003
Decision Date 12/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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