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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K964034
Device Name TRANSJUGULAR ACCESS SET
Original Applicant
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury,  NY  12804
Original Contact brian kunst
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/08/1996
Decision Date 05/06/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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