K232593
- 510(k) number
- K232593
- Device name
- FITme Customized Silicone Implant
- Applicant
- Keosan Trading Co. KR
- Product code
- FWP — Prosthesis, Chin, Internal
- Decision date
- 2023-11-22
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K232593.pdf
Official FDA record: K232593
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.