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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 K873687
Device Name ANGIOMAT CT INJECTOR
Applicant
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Applicant Contact THOMAS DONOHUE
Correspondent
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Correspondent Contact THOMAS DONOHUE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/14/1987
Decision Date 10/09/1987
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
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