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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)
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tono-pen tonometer tip cover Tra & Accessories k033146 11/23/2004
aequalis shoulder fracture system, aequalis reversed shoulder prosthesis, aequalis reversed fracture shoulder prothesis Tornier S.A.S. k131231 10/16/2013
latex examination gloves Top Glove Sdn. Bhd. k913409 09/27/1991
mag vita tms therapy system w/theta burst stimulation Tonica Elektronik A/S k173620 08/14/2018
sysmex r-1000 automated reticulocyte analyzer Toa Medical Electronics USA, Inc. k894539 09/26/1989
thermage thermacool system Thermage, Inc. k000944 07/19/2000
thermage thermacool ii system Thermage, Inc. k003183 12/08/2000
a-port implantable vascular access system line ex. Therex Corp. k903691 10/12/1990
yoshida wave pict cam intraoral camera, sigma biomedics sigmacam intraoral camera The Yoshida Dental Mfg. Co., Ltd. k000577 05/05/2000
powered wheelchair The Oec Group k811656 06/25/1981

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