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U.S. Department of Health and Human Services

510(K) Premarket Notification

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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
solana gas assay, solana instrument QUIDEL CORPORATION k150868 06/23/2015
careview 1500cw x-ray flat panel detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. k150929 08/04/2015
amendia interbody fusion devices AMENDIA, INC. k151322 09/10/2015
8ch foot ankle coil SHENZHEN RFTECH CO., LTD. k151653 08/07/2015
powder free nitrile patient examination gloves, blue color SUQIAN XINGYE GLOVE CO, LTD k151680 02/12/2016
sustain® r spacers, patriot® spacers, caliber® spacers, rise® spacers, coalition® spacers, coalition agx™ spacers, independence® spacers, fortify®-r corpectomy spacers, fortify® i-r corpectomy spacers, xpand®-r corpectomy spacers, niko® corpectomy spacers, monument™ spacers, altera™ spacers, magnif GLOBUS MEDICAL INC. k152022 02/22/2017
dropper hscrp high sensitivity crp control Quantimetrix Corporation k152117 04/21/2016
entuit secure gastrointestinal suture anchor set, entuit secure adjustable gastrointestinal suture anchor set COOK INCORPORATED k152524 09/30/2015
minghao nitrile powder free patient examination gloves, blue color MINGHAO MEDICAL PRODUCTS CO.,LTD. k152707 03/17/2016

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