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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 K953288
Device Name DIASTAT VASCULAR ACCESS GRAFT
Applicant
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86003
Applicant Contact TIMOTHY J RYNN
Correspondent
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
Flagstaff,  AZ  86003
Correspondent Contact TIMOTHY J RYNN
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/14/1995
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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