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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853205
Device Name PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIP
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact STEPHEN M DOYLE
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact STEPHEN M DOYLE
Date Received07/31/1985
Decision Date 09/16/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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