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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K964033
Device Name 3F ANGIOPTIC ANGIOGRAPHIC CATHETER
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Applicant Contact BRIAN KUNST
Correspondent
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Correspondent Contact BRIAN KUNST
Regulation Number870.1200
Classification Product Code
DQO  
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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