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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 E. Galbraith Rd.
Cincinnati,  OH  45237
Applicant Contact DALE MOORE
Correspondent
Mallinckrodt Inc., Liebel-Flarsheim Business
2111 E. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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