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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Occluder, Catheter Tip
510(k) Number K983927
Device Name GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
Applicant
ARTERIAL VASCULAR ENGINEERING, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Applicant Contact DEBORAH L HERRINGTON
Correspondent
ARTERIAL VASCULAR ENGINEERING, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Correspondent Contact DEBORAH L HERRINGTON
Regulation Number870.1370
Classification Product Code
DQT  
Date Received11/05/1998
Decision Date 03/11/1999
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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