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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 K984088
Device Name OPTISTAR MR INJECTOR SYSTEM
Applicant
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI,  OH  45237
Applicant Contact BRIDGET DRAKE
Correspondent
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI,  OH  45237
Correspondent Contact BRIDGET DRAKE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/16/1998
Decision Date 12/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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