Clearance Summary
MICRO-AIRE PULSE LAVAGE received FDA 510(k) clearance under submission number K874504, sponsored by Micro-Aire Surgical Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-12-29.
- Submission: K874504
- Applicant / Sponsor: Micro-Aire Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 1987-12-29
Classification & Regulation
This clearance is catalogued under FDA product code FQH and 21 CFR 880.5475, within the General Hospital review panel as a Class II device.