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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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yooeehouse breast pump Nantong Poly Technology Co., Ltd. k163183 10/02/2017
iba proton therapy system- proteus 235 (proteus one, proteus plus, proteus tk2, proteus class) Ion Beam Applications S.A. k163500 08/17/2017
everyway otc ems, model ev-805 EVERYWAY MEDICAL INSTRUMENT CO., LTD. k162744 08/03/2017
rt300 fes cycle ergometer Restorative Therapies, Inc. k162470 07/11/2017
assuretech panel dip test, assuretech quick cup test ASSURE TECH (HANGZHOU) CO., LTD. k170049 05/02/2017
multipulse hoplus ASCLEPION LASER TECHNOLOGIES GMBH k161257 03/31/2017
amsco v-pro 1 low temperature sterilization system, amsco v-pro 1 plus low temperature sterilization system, v-pro max low temperature sterilization system, v-pro 60 low temperature sterilization system STERIS Corporation k162413 03/31/2017
3.3 mm laurimed microdebrider; 4.0 mm laurimed microdebrider LAURIMED LLC k163247 03/09/2017
my patch sl DMS-SERVICE LLC k163535 02/22/2017
nitrile powder free examination gloves tested for use with chemotherapy drugs (white); dark violet blue (dvbu); dark blue (dkbu) HARTALEGA SDB. BHD. k162924 01/24/2017

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