510(k) K241150
K241150 is an FDA 510(k) premarket notification submitted by Keosan Trading Co. for the device "MISTI Silicone Implant". The FDA issued a decision of Substantially Equivalent on July 24, 2024. The device falls under product code MIB (Elastomer, Silicone Block), a Class II device regulated under 21 CFR 874.3620. Keosan Trading Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2024
- Date Received
- April 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elastomer, Silicone Block
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- SU
- Submission Type