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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 K062161
Device Name GORE PROPATEN VASCULAR GRAFT
Applicant
W.L. GORE & ASSOCIATES,INC
1505 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86003 -3000
Applicant Contact Michael Ivey
Correspondent
W.L. GORE & ASSOCIATES,INC
1505 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86003 -3000
Correspondent Contact Michael Ivey
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/28/2006
Decision Date 11/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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