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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, Absorbable, Abdominal Hernia
510(k) Number K033671
FOIA Releasable 510(k) K033671
Device Name GORE BIOABSORBABLE MESH
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact BRANDON HANSEN
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact BRANDON HANSEN
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
OWZ   OXC  
Date Received11/24/2003
Decision Date 12/31/2003
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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