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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 K040728
Device Name ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
Original Applicant
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury,  NY  12804
Original Contact teri juckett
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/22/2004
Decision Date 06/18/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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