K241150
- 510(k) number
- K241150
- Device name
- MISTI Silicone Implant
- Applicant
- Keosan Trading Co. KR
- Product code
- MIB — Elastomer, Silicone Block
- Decision date
- 2024-07-24
- Date received
- 2024-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241150.pdf
Official FDA record: K241150
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.