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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 K940824
Device Name DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
Applicant
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
P.O. Box 2200
Flagstaff,  AZ  86003
Applicant Contact JAMES D LEWIS
Correspondent
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
P.O. Box 2200
Flagstaff,  AZ  86003
Correspondent Contact JAMES D LEWIS
Regulation Number870.3450
Classification Product Code
DYF  
Date Received01/06/1994
Decision Date 05/04/1994
Decision SE SUBJECT TO TRAKING & PMS (PT)
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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