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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 K043081
Device Name GORE POLYPROPYLENE HERNIA MESH
Applicant
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact Michael Ivey
Correspondent
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact Michael Ivey
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/08/2004
Decision Date 12/22/2004
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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