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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
Applicant
Vascutek, Ltd.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact TEENA M AUGOSTINO
Correspondent
Vascutek, Ltd.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact TEENA M AUGOSTINO
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/14/1995
Decision Date 02/09/1996
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
Recalls CDRH Recalls
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