FDA 510(k) Applications Submitted by KI HAN

FDA 510(k) Number Submission Date Device Name Applicant
K121401 05/10/2012 TENDER TOUCH SOMETECH CORPORATION
K200787 03/26/2020 BSD3543W Bontech Co. Ltd
K031436 05/06/2003 MEDISCOPE SOMETECH CORPORATION
K123821 12/12/2012 AIO HD OTOSCOPE BLUE FOCUS
K024186 12/19/2002 X-VIEW SOMETECH CORPORATION
K191235 05/08/2019 Leltek Ultrasound Imaging System Leltek Inc
K160923 04/04/2016 REDAPT Anteverted Cemented Liner SMITH & NEPHEW, INC.
K171073 04/11/2017 Smith & Nephew, Inc. REDAPT Augments Smith & Nephew, Inc.
K162303 08/17/2016 REDAPT Sleeved Monolithic Revision Stems SMITH & NEPHEW INC.
K051639 06/20/2005 AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM AS SOFTWARE, INC.
K211701 06/03/2021 X-Guide« Surgical Navigation System X-Nav Technologies, LLC
K223499 11/21/2022 Three Way Stop Cock M/s Romsons International


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