Clearance Summary
MICRO-AIRE MODEL NUMBER: MK-426 received FDA 510(k) clearance under submission number K905097, sponsored by Micro Surgical Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1990-12-21.
- Submission: K905097
- Applicant / Sponsor: Micro Surgical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 1990-12-21
Classification & Regulation
This clearance is catalogued under FDA product code HBE and 21 CFR 882.4310, within the Neurology review panel as a Class II device.