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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 K882329
Device Name L-F COILED EXTENSION TUBING
Applicant
MALLINCKRODT GROUP, INC.
2111 EAST GALBRAITH RD.
P.O. BOX 156305
CINCINNATI,  OH  45215 -6305
Applicant Contact THOMAS F DONOHUE
Correspondent
MALLINCKRODT GROUP, INC.
2111 EAST GALBRAITH RD.
P.O. BOX 156305
CINCINNATI,  OH  45215 -6305
Correspondent Contact THOMAS F DONOHUE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/06/1988
Decision Date 09/02/1988
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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