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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
510(k) Number K010810
Device Name DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Applicant Contact JANET G JOHNSON
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Correspondent Contact JANET G JOHNSON
Regulation Number888.3530
Classification Product Code
HRY  
Date Received03/19/2001
Decision Date 04/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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