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U.S. Department of Health and Human Services

510(K) Premarket Notification
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immulite 2000; total t3 calibration verification material, total t4 calibration verification material, total tbg calibra Siemens Healthcare Diagnostics, Inc. k133124 10/25/2013
piezon 250 E.M.S Electro Medical Systems S.A k132445 12/06/2013
biosign flu a + b, status flu a & b Princeton BioMeditech Corp. k133474 12/10/2013
isys 1 (u.s),accessory, non-sterile Isys Medizintechnik GmbH k131433 03/11/2014
geistlich mucograft: 15 x 20 mm, 20 x 30 mm, 8 mm diameter Geistlich Pharma AG k140518 07/18/2014
fingertip pulse oximeter Beijing Choice Electronic Technololgy Co., Ltd. k141128 08/13/2014
hyprocure ii Graham Medical Technologies, LLC Dba Gramedica k142534 10/03/2014
light scalpel Lightscalpel, LLC k141658 10/22/2014
avs® al and align peek spacers, avs® pl and unilif peek spacers, avs® tl peek spacer, avs® navigator peek spacer, avs® aria peek spacer, acculif tl and pl cage, avs® anchor-l spacer, aero-al lumbar cage system Stryker Corporation k143163 01/26/2015
navio Blue Belt Technologies, Inc. k143668 03/20/2015

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