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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)
Number
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Decision
Date
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gangi-softguard coaxial needle, gangi-hydroguard coaxial needle AprioMed AB k181756 12/18/2018
gem hemochron 100 system, gem hemochron 100 activated clotting time plus test (act+), gem hemochron 100 low range activated clotting time test (act-lr), directcheck act+ whole blood control, level 1 and level 2, directcheck act-lr whole blood control, level 1 and level 2 Accriva Diagnostics, Inc. k202101 12/29/2021
gem premier 5000 (measured parameters:glucose, lactate and total bilirubin) Instrumentation Laboratory Co. k160402 12/14/2016
gemss medical systems surgical mobile fluoroscopic x-ray system GEMSS MEDICAL SYSTEMS CO. LTD k132289 06/16/2014
genicon laparoscopes GENICON, LC k030174 06/19/2003
glass ceramic Shenzhen Xiangtong Co.,Ltd. k223194 02/10/2023
gore dryseal sheath W. L. GORE & ASSOCIATES, INC. k120428 04/20/2012
grams absorbable surgical gut suture plain & chromic GRAMSMED LLC k021043 06/21/2002
gtk veress needles Guangzhou T.K Medical Instrument Co., Ltd. k193339 01/30/2020
guthrie latex surgical glove (pre-powdered) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD k001047 04/28/2000

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