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FDA 510(k) Applications Submitted by KI CHEOL 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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