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U.S. Department of Health and Human Services

510(K) Premarket Notification
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solax powered wheelchair Dongguan Prestige Sporting Goods Co., Ltd k182576 05/21/2019
stratafix symmetric pds plus knotless tissue control devices, stratafix spiral pds plus knotless tissue control devices, stratafix spiral monocryl plus knotless tissue control devices, stratafix spiral monocryl knotless tissue control devices Ethicon, Inc. k182873 01/10/2019
planet onco dose DOSIsoft k182966 03/06/2019
head coil – 12, head coil – 32, carotid coil – 8, temporomandibular joint coil – 4, infant coil – 24, cardiac coil – 24, foot & ankle coil - 24 Shanghai United Imaging Healthcare Co., Ltd. k183186 02/08/2019
preat abutments Preat Corporation k183518 03/18/2019
bc-001+ acne purifier Oriental Inspiration Limited k170260 04/25/2017
powder free nitrile patient examination glove, blue colored, non-sterile, polymer coated, tested for use with chemotherapy drugs; powder free nitrile patient examination glove, white colored, non-sterile, polymer coated, tested for use with chemotherapy drugs Kossan International Sdn. Bhd. k170397 07/10/2017
non contact infrared forehead thermometer Intrinity Global Limited k170662 11/22/2017
scian automatic digital blood pressure monitor, model: ld-576, ld-575 & ld-579 Honsun(Nantong)Co.,Ltd k170866 02/21/2018
sterile polyisoprene powder free surgical gloves Better Care Plastic Technology Co.,Ltd. k171047 06/22/2017

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