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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K031571
Device Name EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
Applicant
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Applicant Contact STEVEN HARTMAN
Correspondent
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Correspondent Contact STEVEN HARTMAN
Regulation Number870.1650
Classification Product Code
IZQ  
Subsequent Product Code
JAK  
Date Received05/20/2003
Decision Date 06/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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