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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 K081069
Device Name GORE INFINIT MESH
Applicant
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21921
Applicant Contact MICHAEL J TITUS
Correspondent
W.L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21921
Correspondent Contact MICHAEL J TITUS
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/15/2008
Decision Date 05/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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