Clearance Summary
MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST received FDA 510(k) clearance under submission number K933811, sponsored by Pitt Enterprises (Silicone) , Ltd.. 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 1994-05-12.
- Submission: K933811
- Applicant / Sponsor: Pitt Enterprises (Silicone) , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1994-05-12
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.