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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
510(k) Number K030782
Device Name SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact MIKE JOHNSON
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact MIKE JOHNSON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/11/2003
Decision Date 04/21/2003
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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