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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K951602
Device Name PULSE*SPRAY INFUSION SYSTEM
Applicant
Angiodynamics, Div. E-Z-Em, Inc.
266 Queensbury Ave.
Queensbury,  NY  12804
Applicant Contact JODI L FRASIER
Correspondent
Angiodynamics, Div. E-Z-Em, Inc.
266 Queensbury Ave.
Queensbury,  NY  12804
Correspondent Contact JODI L FRASIER
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/14/1995
Decision Date 06/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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