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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 K953287
Device Name DIASTAT VASCULAR ACCESS GRAFT
Applicant
W.L. GORE & ASSOCIATES,INC
1505 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86003 -3000
Applicant Contact TIMOTHY J RYNN
Correspondent
W.L. GORE & ASSOCIATES,INC
1505 NORTH FOURTH ST.
FLAGSTAFF,  AZ  86003 -3000
Correspondent Contact TIMOTHY J RYNN
Regulation Number870.3450
Classification Product Code
DYF  
Date Received07/13/1995
Decision Date 10/06/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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