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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K001738
Device Name DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
Applicant
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact MARCIA J ARENTZ
Correspondent
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact MARCIA J ARENTZ
Regulation Number878.3300
Classification Product Code
FTM  
Date Received06/07/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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