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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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bladder scanner Caresono Technology Co., Ltd. k153581 04/08/2016
h/s catheter set CATHETER RESEARCH, INC. k032835 12/11/2003
cefaly dual enhanced with rfid - otc, cefaly dual enhanced with rfid - rx, cefaly dual connected - otc, cefaly dual connected - rx CEFALY Technology k212071 12/13/2022
maia, model 1 CENTERVUE SPA k092187 05/27/2010
non sterile powder free polyurethane examination gloves (blue and black colors) Central Medicare Sdn Bhd k203036 05/07/2021
senzzzzz away CENTRIX, INC. k120176 07/25/2012
certa dose pd epinephrine 1mg/ml im/sc syringe CERTA DOSE, INC. k160589 01/19/2017
chad therapeutics oxypenumatic cypress model 511 CHAD THERAPEUTICS, INC. k020475 07/05/2002
aik sterile acupuncture needles for single use CHANGCHUN AIK MEDICAL DEVICES CO., LTD k162566 05/11/2017
aquadex flexflow system CHF SOLUTIONS, INC. k071854 09/07/2007

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