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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K963611
Device Name VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
Applicant
VASCUTEK LTD.
1300 EAST ANDERSON LN.
AUSTIN,  TX  78752
Applicant Contact TEENA M AUGOSTINO
Correspondent
VASCUTEK LTD.
1300 EAST ANDERSON LN.
AUSTIN,  TX  78752
Correspondent Contact TEENA M AUGOSTINO
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received09/10/1996
Decision Date 11/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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