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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K953825
Device Name ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
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 Number880.5440
Classification Product Code
FPA  
Date Received08/15/1995
Decision Date 02/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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