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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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disposable intermittent catheter (tpu catheter) Chengdu Daxan Innovative Medical Tech. Co., Ltd. k243175 06/26/2025
champions implants gmbh mimi 1-piece precision implant, model 1000 up to 6000 Champions Implants GmbH k091182 01/07/2010
cera-chek 1070 blood glucose monitoring system Ceragem Medisys, Inc. k131727 02/28/2014
legionella indirect fluor. antibody Centers for Disease Control and Prevention k812007 09/08/1981
disposable neutral electrode gp202 Cathay Manufacturing Corp. k130027 08/22/2013
vasopouse deep vein thrombosis compression device model ipcs, model sqs Caremed Supply, Inc. k122873 01/15/2013
diamondback 360 degree orbital atherectomy system Cardiovascular Systems, Inc. k072800 10/25/2007
commander iii non-invasive blood pressure system Cardiocom, LLC k053304 12/30/2005
card guard personal electrocardiogram transmitter, model cg-6206/6306 Card Guard Scientific Survival , Ltd. k000225 02/11/2000
datacaptor Capsule Technologie k013019 12/18/2001

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