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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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Applicant
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510(K)
Number
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Decision
Date
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classic intermittent catheter Flexicare Medical, Ltd. k132619 10/11/2013
fisher diagnostics thromboscreen 1000; pacific hemostasis fibrinogen reagent plus kaolin Fisher Diagnostics k023362 12/09/2002
opus hc482 direct nasal mask Fisher & Paykel Healthcare, Ltd. k063036 12/22/2006
fst cath ud-dual dual pressure catheter Fiberoptic Sensor Technlogies, Inc. k926088 06/18/1993
easy shield adhesive bandage Eye Garter Company, Inc. k880675 04/01/1988
exeter lip seal Exeter Medical Labs, Inc. k790554 04/10/1979
everyway analog otc tens, model n103a/n302 Everyway Medical Instruments Co.,Ltd k202849 12/22/2020
supascoota motorized vehicle - spartan (sumo)/ spartan sp (sumo sp) Eurogreen International, Inc. k182631 09/19/2019
espe(r) -sil Espe GmbH (Us) k913965 12/04/1991
dialyzer (model 1850) Erika, Inc. k760374 10/27/1976

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