Clearance Summary
MAR-MED LIVER STRAP received FDA 510(k) clearance under submission number K924223, sponsored by Mar-Med Co.. 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 1993-03-18.
- Submission: K924223
- Applicant / Sponsor: Mar-Med Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1993-03-18
Classification & Regulation
This clearance is catalogued under FDA product code GDJ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.