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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
Device Name GORE BIOABSORBABLE MESH
Original Applicant
W. L. GORE & ASSOCIATES, INC.
3450 west kiltie ln.
flagstaff,  AZ  86001
Original 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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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