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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 K053202
Device Name GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W.L. GORE & ASSOCIATES
3450 W. KILTIE LANE
FLAGSTAFF,  AZ  86001
Applicant Contact Michael Ivey
Correspondent
W.L. GORE & ASSOCIATES
3450 W. KILTIE LANE
FLAGSTAFF,  AZ  86001
Correspondent Contact Michael Ivey
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/16/2005
Decision Date 12/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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