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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name injector, contrast medium, automatic
510(k) Number K063503
FOIA Releasable 510(k) K063503
Device Name OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
Applicant
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI,  OH  45237
Applicant Contact DALE MOORE
Correspondent
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI,  OH  45237
Correspondent Contact DALE MOORE
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received11/20/2006
Decision Date 04/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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