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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mechanical thrombolysis catheter
510(k) Number K961763
Device Name PULSE*SPRAY INFUSION SYSTEM
Applicant
ANGIODYNAMICS, DIV. E-Z-EM, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Applicant Contact BRIAN KUNST
Correspondent
ANGIODYNAMICS, DIV. E-Z-EM, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Correspondent Contact BRIAN KUNST
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received05/07/1996
Decision Date 07/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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