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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 Less Then 6mm Diameter
510(k) Number K991683
Device Name PTFE RINGED GORE-TEX VASCULAR GRAFT
Applicant
W.L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
P.O. Box 2400
Flagstaff,  AZ  86001 -0300
Applicant Contact TIMOTHY J RYNN
Correspondent
W.L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
P.O. Box 2400
Flagstaff,  AZ  86001 -0300
Correspondent Contact TIMOTHY J RYNN
Regulation Number870.3450
Classification Product Code
DYF  
Date Received05/17/1999
Decision Date 09/08/1999
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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