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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 K955230
Device Name VASCUTEK GELSOFT PLUS VASCULAR GRAFT
Original Applicant
VASCUTEK LTD.
1300 east anderson ln.
austin,  TX  78752
Original Contact teena m augostino
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/14/1995
Decision Date 02/09/1996
Decision (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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