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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K011160
Device Name E-Z EM PERCUPUMP 2001 CT INJECTOR
Applicant
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Applicant Contact BOB WILLIAMS
Correspondent
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Correspondent Contact BOB WILLIAMS
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
DSB  
Date Received04/16/2001
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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