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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)
Number
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Decision
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xingda nitrile powder free patient examination gloves, blue color Xingda Medical Products Co., Ltd. k152720 03/10/2016
xn cal Streck k120745 10/19/2012
xpr printer redundancy Vortech Data, Inc. k914444 02/27/1992
yoshida wave pict cam intraoral camera, sigma biomedics sigmacam intraoral camera The Yoshida Dental Mfg. Co., Ltd. k000577 05/05/2000
yushan x-ray flat panel detector Innocare Optoelectronics Corp. k191939 08/29/2019
yuwell infrared ear thermometer: yht101, yht200 Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. k203583 05/20/2021
zip'r mantis powered wheelchair Global Fabtech Wheelchair (Shanghai) Co., Ltd. k102355 10/04/2010
zodiac spinal fixation system Alphatec/Nexmed k050830 06/22/2005

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