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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 K071378
Device Name MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
Applicant
E-Z-Em, Inc.
750 Summa Ave.
Westbury,  NY  11590
Applicant Contact STEVEN HARTMAN
Correspondent
E-Z-Em, Inc.
750 Summa Ave.
Westbury,  NY  11590
Correspondent Contact STEVEN HARTMAN
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
DSB   IZQ  
Date Received05/17/2007
Decision Date 06/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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