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U.S. Department of Health and Human Services

510(K) Premarket Notification
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asd oral appliances AMERICAN SLEEP DENTISTRY k163580 06/08/2017
u2 femoral head UNITED ORTHOPEDIC CORPORATION k162957 07/17/2017
synthetic nitrile patient examination gloves, powder free, blue color, and tested for use with chemotherapy drugs SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD k170136 08/25/2017
vma™ system version 3.0 Ortho Kinematics, Inc. k172327 08/25/2017
k2m navigation instruments K2M k171321 08/30/2017
careview 1800cw x-ray flat panel detectors CareRay Digital Medical System Co., Ltd. k172581 09/26/2017
3m tegaderm antimicrobial transparent dressing, 3m tegaderm antimicrobial i.v. advanced securement dressing 3M Company, 3M Health Care k170754 11/21/2017
suction irrigation set WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. k172794 11/29/2017
cotton-huibregtse stent, cotton-leung biliary stent, cotton-leung sof-flex biliary stent, soehendra tannenbaum biliary stent, zimmon biliary stent, guiding catheter, pushing catheter, fusion pushing catheter, stent introducer set, fusion oasis one action sent introduction system, zimmon biliary ste Cook Ireland Ltd k172044 02/27/2018
nathanson transcystic bile duct stone exploration pack Cook Incorporated k171915 03/01/2018

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