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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K060696
Device Name ACCLAIM TOTAL ELBOW SYSTEM
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr., P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact NATALIE S HECK
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr., P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact NATALIE S HECK
Regulation Number888.3150
Classification Product Code
JDC  
Subsequent Product Code
JDB  
Date Received03/16/2006
Decision Date 04/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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