Clearance Summary
MEDI-SOL received FDA 510(k) clearance under submission number K924571, sponsored by Orange-Sol, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-04-06.
- Submission: K924571
- Applicant / Sponsor: Orange-Sol, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4730
- Decision date: 1993-04-06
Classification & Regulation
This clearance is catalogued under FDA product code KOX and 21 CFR 878.4730, within the General, Plastic Surgery review panel as a Class I device.