Clearance Summary
MICRO-AIRE MODEL 2060 received FDA 510(k) clearance under submission number K913369, sponsored by Micro Surgical Instruments Corp.. 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 1991-11-01.
- Submission: K913369
- Applicant / Sponsor: Micro Surgical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1991-11-01
Classification & Regulation
This clearance is catalogued under FDA product code GEY and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.