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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 K964665
Device Name VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
Applicant
Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact TEENA M AUGOSTINO
Correspondent
Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact TEENA M AUGOSTINO
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/21/1996
Decision Date 02/19/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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