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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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slimming treatment device Beijing Honkon Technologies Co., Ltd. k161892 03/02/2017
loyon Oculus Innovative Sciences k162217 03/23/2017
sterile polyisoprene powder free surgical gloves Better Care Plastic Technology Co., Ltd. k171047 06/22/2017
medline renewal reprocessed sonicision cordless ultrasonic dissector Surgical Instrument Service and Savings Inc.(Dba Medline Ren k170955 07/03/2017
tigr matrix surgical mesh Novus Scientific AB k163005 07/27/2017
osteotomy truss system (ots) 4Web, Inc. k172294 02/22/2018
web ii memory extraction basket or memory ii double lumen extraction basket, memory 5 fr. soft wire baskets or memory helical stone extractor, memory eight wire baskets or memory hard wire baskets, fusion wire guided extraction basket, non-lithotripsy extraction basket Wilson-Cook Medical, Inc. k171969 03/28/2018
48ch head coil Ge Healthcare Coils (Usa Instruments, Inc.) k180666 04/12/2018
self-adhesive electrode Dong Guan OU Kang Electronics Co., Ltd. k181234 08/07/2018
mag vita tms therapy system w/theta burst stimulation Tonica Elektronik A/S k173620 08/14/2018

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