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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K933846
Device Name ANGIOGRAPHY SYRINGE KITS
Applicant
Angiodynamics, Div. E-Z-Em, Inc.
P.O. Box 993
266 Queensbury Ave.
Glens Falls,  NY  12801
Applicant Contact MERRIBETH ADAMS
Correspondent
Angiodynamics, Div. E-Z-Em, Inc.
P.O. Box 993
266 Queensbury Ave.
Glens Falls,  NY  12801
Correspondent Contact MERRIBETH ADAMS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/06/1993
Decision Date 12/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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