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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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electronic blood pressure monitor SHENZHEN URION TECHNOLOGY CO., LTD. k141683 04/03/2015
garment electrodes SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. k141076 11/14/2014
comborehab SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. k150436 11/13/2015
tens and powered muscle stimulator SHENZHEN AS-TEC TECHNOLOGY CO., LTD k143268 07/21/2015
disposable powdered nitrile exam glove, white color SHEEN MORE ENT. CO., LTD. k001155 05/23/2000
sheathes ultrasond gel SHEATHING TECHNOLOGIES, INC. k112827 06/22/2012
disposable angiographic syringe, model(s) ct-200-ne, ct-200-ma, ct-200+200-ma, ct-200-lf, ct -100-ne, ct-200ne, ct-50+ct SHANDONG WEIGAO MEDICAL POLYMER CO., LTD k082439 03/23/2009
sentinel plasmaproteins cal 3x SENTINEL CH. SpA k081533 06/25/2008
sensaid, models# rc-nva30-10; rc-cs140-10; rc-bc150-3 SENSIDYNE, INC. k021246 05/13/2002
pad (personal alcohol detector) breath alcohol test system SEJU ENGINEERING CO., LTD. k110614 11/21/2011

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