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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 Dr.,
Warsaw,  IN  46582
Applicant Contact RHONDA MYER
Correspondent
Depuy Synthes
3 Main St.
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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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