FITme Customized Silicone Implant
FDA 510(k) clearance K232593 · decided 2023-11-22
Clearance details
- K-number
- K232593
- Device name
- FITme Customized Silicone Implant
- Applicant
- Keosan Trading Co.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-25
- Decision date
- 2023-11-22
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.