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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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K102080
Device Name DEPUY RECLAIM REVISION HIP SYSTEM
Applicant
DEPUY (IRELAND)
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46582
Applicant Contact RHONDA MYER
Correspondent
DePuy Synthes
3 Main Street
Ringaskiddy,  IE
Correspondent Contact Jennifer Hill
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/26/2010
Decision Date 11/23/2010
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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