Clearance Summary
ELECTROSURGERY ANALYZER RF302 received FDA 510(k) clearance under submission number K893659, sponsored by Bio-Tek Instruments, 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 1989-07-14.
- Submission: K893659
- Applicant / Sponsor: Bio-Tek Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1989-07-14
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.