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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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