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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
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bone-dri surgical sponge HOWMEDICA CORP. k803125 01/15/1981
briefcase-quantification Aidoc Medical, Ltd. k231631 11/28/2023
bti interna narrow/plus dental implant system unicca B.T.I. Biotechnology Institute, SL k211952 07/21/2022
bulk fill flowable composite NOVOCOL, INC. k141994 11/14/2014
bx transhepatic biliary stent and delivery system CORDIS CORP. k001258 06/27/2000
c510g/jusha-c510g/c510/jusha- c510 lcd monitor Nanjing Jusha Display Technology Co., Ltd k230723 05/18/2023
cannabinoids urine test Guangzhou Wondfo Biotech Co., Ltd. k110182 05/20/2011
capiox rx05 hollow fiber oxygenator/reservoir TERUMO Corporation k130493 03/13/2013
carcino-cek BIOLOGICS INTL., INC. k823353 12/14/1982
cardiochek plus test system; cardiochek plus home test system Polymer Technology Systems, Inc. d/b/a PTS Diagnostics k193406 02/26/2022

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