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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 K992656
Device Name DEPUY TOTAL ELBOW SYSTEM
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 Number888.3150
Classification Product Code
JDC  
Subsequent Product Code
JDB  
Date Received08/09/1999
Decision Date 11/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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