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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 K991602
Device Name EPTFE RINGED GORE-TEX VASCULAR GRAFT
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86002
Applicant Contact TIMOTHY J RYAN
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff,  AZ  86002
Correspondent Contact TIMOTHY J RYAN
Regulation Number870.3450
Classification Product Code
DSY  
Date Received05/10/1999
Decision Date 07/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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