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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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fisher diagnostics thromboscreen 1000; pacific hemostasis fibrinogen reagent plus kaolin Fisher Diagnostics k023362 12/09/2002
flexible fiber-optic nasopharyngoscope Optimed Technologies, Inc. k895245 11/17/1989
flexible ureterorenoscope (us27f-12-eu; us27f-12-us) Shanghai AnQing Medical Instrument Co., Ltd. k243857 04/11/2025
flexiflo low-profile balloon gastrostomy tube Abbott Laboratories k962554 11/07/1997
flo trac sensor, volume view sensor Edwards Lifesciences, LLC k152980 01/19/2016
flowers medial malar implant Implantech Associates, Inc. k921582 05/06/1992
flowguard catheters & cannalae Advocacy International, Ltd. k813037 12/14/1981
forceps, surgical gynecological Owens Precision Systems, Inc. k944055 09/20/1994
fox post nasal balloon catheter Inmed Corp. k841040 08/17/1984
fresenius a2008 hemodialysis machine expansion mod Seratronics, Inc. k844750 02/15/1985

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