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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 K070644
Device Name GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
Applicant
W.L. Gore & Associates, Inc.
301 Airport Rd.
P.O. Box 1408
Elkton,  MD  21922 -1408
Applicant Contact BARBARA L SMITH
Correspondent
W.L. Gore & Associates, Inc.
301 Airport Rd.
P.O. Box 1408
Elkton,  MD  21922 -1408
Correspondent Contact BARBARA L SMITH
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/08/2007
Decision Date 04/02/2007
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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