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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, Polymeric
510(k) Number K964761
Device Name S.A.M. FACIAL IMPLANT W/INTRODUCER
Applicant
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922 -1408
Applicant Contact JOHN W NICHOLSON
Correspondent
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21922 -1408
Correspondent Contact JOHN W NICHOLSON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/27/1996
Decision Date 01/27/1997
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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