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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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fiber hemofilters fh55-fh77 & 88 Gambro, Inc. k840720 04/24/1984
femoral canal brush Richard'S Medical Equip., Inc. k810267 02/09/1981
fdr d-evo gl flat panel detector system Fujifilm Medical System U.S.A., Inc. k152138 11/05/2015
f/ls mca application software Instrumentation Laboratory CO k801456 10/03/1980
external female urinary incontinence The Healthcare Group Laboratories, Inc. k821172 05/10/1982
exeter lip seal Exeter Medical Labs, Inc. k790554 04/10/1979
evita 4 Drager, Inc. k961687 12/13/1996
everyway analog otc tens, model n103a/n302 Everyway Medical Instruments Co.,Ltd k202849 12/22/2020
everest spinal system K2m, Incorporated k161369 07/21/2016
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

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