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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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