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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
Number
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Decision
Date
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micresurgical tray, sm.,med., & lg. Edward Weck, Inc. k800367 03/10/1980
ebi xfix dfs metaphyseal correction system Ebi, L.P. k001358 05/23/2000
model 2/2 analyzer Eastman Kodak Company k771245 10/07/1977
kodak surecell hcg-serum/urine test kit, modification Eastman Kodak Company k936138 04/08/1994
bcd-hpp41c interface Dynatech Corp. k810968 04/23/1981
guinea pig blood in alsever's, cit., def Dutchland Laboratories, Inc. k812372 09/09/1981
eva,anterior machine, eva, combined machine, eva combined machine with laser(dorc connector), eva combined machine with laser sma connector) Dutch Ophthalmic Research Center International BV k142877 03/13/2015
db precision implant system Driskell Bioengineering k853788 10/31/1985
evita 4 Drager, Inc. k961687 12/13/1996
infinity delta/delta xl/ kappa/ gamma x xl/ vista xl/ sc7000/sc8000/ sc9000xl Draeger Medical Systems, Inc. k070566 06/04/2007

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