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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, Non-Absorbable, Staple Line Reinforcement
510(k) Number K001789
Device Name SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86002
Applicant Contact R. LARRY PRATT
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86002
Correspondent Contact R. LARRY PRATT
Regulation Number878.3300
Classification Product Code
OXD  
Date Received06/13/2000
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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