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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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single-use latex sterile surgical gloves (sg100) Fitone Latex Products Co., Ltd. Guangdong k231446 09/22/2023
pre-set 50/50 nitrous oxide/oxygen mixer FRASER SWEATMAN, INC. k760766 10/08/1976
5008x hemodialysis system Fresenius Medical Care k231534 02/02/2024
multiple tubing segment set with stay safe pin connectors, stay safe drain set Fresenius Medical Care Renal Therapies Group, LLC k173651 02/14/2018
acetic acid wand, acid wand assembly, bicarbonate wand assembly FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER k133299 07/07/2014
fujifilm ultrasonic endoscope eg-740ut FUJIFILM Corporation k221238 08/19/2022
gambro cartridge blood sets GAMBRO RENAL PRODUCTS k070414 10/12/2007
gf-120-l dialyzer GAMBRO, INC. k801370 07/21/1980
gambro lundia plate disp. dialyzer GAMBRO, INC. k802389 12/22/1980
ultrafiltration monitor ufm-10-2 GAMBRO, INC. k830596 04/27/1983

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