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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 K042744
Device Name OPTIV ANTAGE DH POWER INJECTION SYSTEM
Applicant
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI,  OH  45237
Applicant Contact ELLIS ROGERS
Correspondent
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI,  OH  45237
Correspondent Contact ELLIS ROGERS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/04/2004
Decision Date 11/30/2004
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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