Clearance Summary
ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES received FDA 510(k) clearance under submission number K994333, sponsored by Oratec Interventions, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2000-01-18.
- Submission: K994333
- Applicant / Sponsor: Oratec Interventions, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2000-01-18
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.