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U.S. Department of Health and Human Services

510(K) Premarket Notification
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werewolf rf20000 controller, flow 50 wand ARTHROCARE CORPORATION k162074 08/22/2016
cardiochek plus test system, cardiochek home test system Polymer Technology Systems, Inc. d/b/a PTS Diagnostics k162282 12/22/2016
caas mr 4d flow PIE MEDICAL IMAGING B.V. k162376 12/08/2016
squirt fluid delivery system Merit Medical Systems, Inc. k162777 10/31/2016
unomedical comfort subcutaneous infusion set, unomedical comfort short subcutaneous infusion set, unomedical neria soft subcutaneous infusion set, medtronic silhouette subcutaneous infusion set, medtronic silhouette paradigm subcutaneous infusion set, roche accu-chek tender subcutaneous infusion se UNOMEDICAL A/S k162812 11/01/2017
smartgrid Carestream Health k163157 03/21/2017
viva nasal mask (model: nm4), numa full face mask (model: bmc-fm2) BMC MEDICAL.,LTD. k163464 09/05/2017
hitachi supria whole-body x-ray ct system phase 3 Hitachi Medical Systems America, Inc. k163528 03/03/2017
s30/s40 digital color doppler ultraound system SONOSCAPE COMPANY LIMITED k150045 04/28/2015
alfasight 9000 thermographic system ALFA THERMODIAGNOSTICS, INC. k150457 04/10/2015

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