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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)
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Decision
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disposable abdominal trocars (bladed trocars, bladeless trocars, optical trocars) Jiangsu Channel Medical Device Co., Ltd. k232866 11/07/2023
dispos gel external pacing electrode/hi impedance Medac, Inc. k864987 03/03/1987
dinamap vital signs monitor model 8100 Critikon Company, LLC k854434 05/16/1986
digital thermometer(with disposable thermometer cover) Hangzhou Hua'An Medical&Health Instruments Co.,Ltd k172861 12/19/2017
digital thermometer Micro Idea Instrument Co., Ltd. k851146 05/23/1985
dideco lilliput 1 twin reservoir with phosphorilcholine insert surface in oxygenation (ph. i.s.i.o.) Dideco S.P.A. k001602 06/08/2000
diamond (mammographic x-ray system) Instrumentarium Imaging, Inc. k000976 06/01/2000
diacrom *plg Wellcome Diagnostics k832591 11/21/1983
dey-pak purified water, usp, sterile Dey Laboratories, Inc. k875011 01/22/1988
dexcom g7 continuous glucose monitoring (cgm) system, dexcom g7 15 day continuous glucose monitoring (cgm) system Dexcom, Inc. k253710 12/17/2025

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