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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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forceps, surgical gynecological Owens Precision Systems, Inc. k944055 09/20/1994
flowguard catheters & cannalae Advocacy International, Ltd. k813037 12/14/1981
flowers medial malar implant Implantech Associates, Inc. k921582 05/06/1992
flo trac sensor, volume view sensor Edwards Lifesciences, LLC k152980 01/19/2016
flexiflo low-profile balloon gastrostomy tube Abbott Laboratories k962554 11/07/1997
flexible ureterorenoscope (us27f-12-eu; us27f-12-us) Shanghai AnQing Medical Instrument Co., Ltd. k243857 04/11/2025
flexible fiber-optic nasopharyngoscope Optimed Technologies, Inc. k895245 11/17/1989
fisher diagnostics thromboscreen 1000; pacific hemostasis fibrinogen reagent plus kaolin Fisher Diagnostics k023362 12/09/2002
first response 10 minute ovulation predictor test Tambrands, Inc. k883530 12/19/1988
fibergraft™ bg putty gps bone graft substitute fibergraft™ bg putty bone graft substitute fibergraft™ aeridyan™ matrix bone graft substitute fibergraft™ bg matrix bone graft substitute Prosidyan, Inc. k253147 10/22/2025

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