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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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Decision
Date
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kinematic rotating hinge total knee pr. HOWMEDICA CORP. k811630 07/01/1981
kimguard one-step sterilization wrap KIMBERLY-CLARK CORP. k082177 03/27/2009
jusha-m350g/jusha-m350/m350g/m350 lcd monitor Nanjing Jusha Display Technology Co., Ltd k183499 02/04/2019
juliet ti Spineart k181203 06/28/2018
jms planecta stopcock JMS NORTH AMERICA CORP. k070143 04/10/2007
jetpack 2.0 PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. k111024 04/21/2011
jet ventilator HEALTHDYNE, INC. k813254 02/04/1982
jacob wirz transfixation pin COLMED, LTD. k811209 06/16/1981
irts thermal imaging probe (tip);irts patient monitoring unit (pmu);irts patient interface unit (piu) SECURUS,INC k152402 03/04/2016
irradiation aesthetic device Chongqing Peninsula Medical Technology Co., Ltd. k171835 01/30/2018

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