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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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kodak color medical imager 1000 EASTMAN KODAK COMPANY k042159 09/24/2004
modification to dimension nt-probnp flex reagent cartridge method DADE BEHRING, INC. k042347 11/19/2004
adventure a10 ULRICH ALBER GMBH k042535 10/05/2004
optima mx BIEN-AIR SA SWITZERLAND k042759 10/20/2004
ameditech immutest multi-drug screen panel ii AMEDITECH, INC. k042975 12/29/2004
modification to mbcp BIOMATLANTE k043005 05/03/2005
dragon heart i.v. set DRAGON HEART MEDICAL DEVICES CO., LTD. k043235 03/08/2005
evis exera colonovideoscope model xcf-q160w1l/1 AIZU OLYMPUS CO., LTD. k043487 01/28/2005
ebi trochanteric nail system EBI, L.P. k050118 02/16/2005
roche diagnostics elecsys precicontrol tumor ROCHE DIAGNOSTICS CORP. k050387 04/25/2005

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