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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K013250
Device Name GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
Applicant
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Applicant Contact TIMOTHY J RYNN
Correspondent
W.L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86001
Correspondent Contact TIMOTHY J RYNN
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/28/2001
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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