Clearance Summary
ACMI ASPIRATOR KIT #8808 received FDA 510(k) clearance under submission number K811218, sponsored by American Cystocope Makers, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1981-07-01.
- Submission: K811218
- Applicant / Sponsor: American Cystocope Makers, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 1981-07-01
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.