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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 K023183
FOIA Releasable 510(k) K023183
Device Name MEDRAD STELLANT CT INJECTOR SYSTEM
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact FRANK W PELC III
Correspondent
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Correspondent Contact FRANK W PELC III
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/24/2002
Decision Date 01/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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