FDA.report

510(k) K232593

Device
FITme Customized Silicone Implant
Applicant
Keosan Trading Co.
510(k) number
K232593
Product code
FWP
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-22
Date received
2023-08-25
Regulation
878.3550
Classification name
Prosthesis, Chin, Internal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Priscilla Chung
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

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