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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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zoll e series with see-thru cpr ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS k070455 04/26/2007
zoll m series nibp option ZOLL MEDICAL CORP. k032363 10/31/2003
ardis interbody system ZIMMER SPINE, INC k131242 09/03/2013
single use cytology brush Zhejiang Chuangxiang Medical Technology Co., Ltd. k220063 07/28/2022
leg and foot air wave pressure therapy device Zhangzhou Easepal Innovation Co Ltd. k223464 03/14/2023
eye secret 38 uv aspheric (polymacon) soft (hydrophilic) contact lens for daily wear, eye secret 55 uv aspheric ( methafilcon a) soft (hydrophilic) contact lens for daily wear YUNG SHENG OPTICAL CO., LTD. k150630 06/15/2015
powder-free vinyl patient examination gloves, clear(non-colored) YUANHANG PLASTIC CO., LTD k122835 12/10/2012
non-sterile, powder-free, polymer coated, natural and/or violet and black color, latex examination gloves with protein YTY INDUSTRY (MANJUNG) SDN. BHD. k030164 03/07/2003
air pressure therapy system Xiamen Weiyou Intelligent Technology Co.,Ltd k201935 06/22/2021
powder free nitrile surgical glove, sterile, tested for use with chemotherapy drugs WRP ASIA PACIFIC SDN BHD k203030 06/11/2021

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