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510(k) K241150

Device
MISTI Silicone Implant
Applicant
Keosan Trading Co.
510(k) number
K241150
Product code
MIB
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-24
Date received
2024-04-25
Regulation
874.3620
Classification name
Elastomer, Silicone Block
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jiyoung Nam
Address
#805, #806, Human Teco B/D, 57, Achasan-Ro 17-Gil Seongdong-Gu Seoul KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MIB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.2023-02-03
K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.2022-12-23
K200073AugMENTA Penile ImplantAugmenta, LLC2022-09-30
K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.2022-05-13
K193392BioSiCar Silicone ImplantMetalware Technology Corp.2020-07-20
K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.2019-01-23
K171851SOFTXILBistool2018-03-16
K162624Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.2017-02-01
K052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XImplantech Associates, Inc.2005-11-04
K052505CALF IMPLANT, MODEL EC17-XImplantech Associates, Inc.2005-11-04
K042054SILIMED PECTORAL IMPLANTSilimed, Inc.2005-02-23
K042380SILICONE BLOCKNational Medical Devices, Inc.2004-10-25
K040042MEDISIL SILICONE SHEETINGMedisil Corporation2004-04-01
K030808HANSON MEDICAL CALF IMPLANTHanson Medical, Inc.2003-04-21
K030809HANSON MEDICAL GLUTEAL IMPLANTHanson Medical, Inc.2003-04-21