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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 K901641
Device Name AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
Applicant
W.L. GORE & ASSOCIATES,INC
3450 WEST KILTIE LN.
P.O. BOX 500
FLAGSTAFF,  AZ  86002
Applicant Contact VICKI LEWIS
Correspondent
W.L. GORE & ASSOCIATES,INC
3450 WEST KILTIE LN.
P.O. BOX 500
FLAGSTAFF,  AZ  86002
Correspondent Contact VICKI LEWIS
Regulation Number870.3450
Classification Product Code
DSY  
Date Received04/09/1990
Decision Date 09/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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