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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 K912944
Device Name CT 8000 DIGITAL INJECTION SYSTEM
Applicant
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Applicant Contact MARK L FREIDMAN
Correspondent
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Correspondent Contact MARK L FREIDMAN
Regulation Number870.1650
Classification Product Code
DXT  
Date Received07/05/1991
Decision Date 02/04/1992
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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