Clearance Summary
ESB 2400 SEI received FDA 510(k) clearance under submission number K933146, sponsored by Esb, Inc., Div. of Ray-O-Vac. 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 1993-09-23.
- Submission: K933146
- Applicant / Sponsor: Esb, Inc., Div. of Ray-O-Vac
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1993-09-23
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.