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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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gabriel feeding tube with balloon, and enfit connector Syncro Medical Innovations, Inc. k191784 11/15/2019
g-thawkit blast VITROLIFE AB k032155 05/07/2004
fully automatic electronic blood pressure monitor, models kd-738 and kd-739 ANDON HEALTH CO.,LTD k092045 07/30/2009
full auto tonometer model tx-20 CANON, INC.-MEDICAL EQUIPMENT GROUP k111710 09/20/2011
freedom CARBONITE CORP. k823849 04/12/1983
fora advanced gd40 glucose, ß-ketone and cholesterol monitoring system TaiDoc Technology Corporation k201037 06/16/2022
flurometer, dade DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. k782150 02/15/1979
fluoride varnish DENTSPLY INTL. k031932 09/15/2003
flosure ventilation patch SIMEX MEDIZINTECHNIK GmbH k150459 01/05/2016
flexcath select steerable sheath (10 french) Medtronic CryoCath LP k142684 11/06/2014

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