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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 K872084
Device Name POROCOAT MARK II TOTAL ELBOW
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact BARRY R SISSON
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact BARRY R SISSON
Regulation Number888.3150
Classification Product Code
JDC  
Date Received05/29/1987
Decision Date 06/25/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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