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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, Staple Line Reinforcement
510(k) Number K150551
Device Name GORE SEAMGUARD Reinforcement
Applicant
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Applicant Contact BARBARA L. SMITH
Correspondent
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Correspondent Contact BARBARA L. SMITH
Regulation Number878.3300
Classification Product Code
OXC  
Date Received03/04/2015
Decision Date 03/30/2015
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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