Clearance Summary
EAR-A-GATOR received FDA 510(k) clearance under submission number K946108, sponsored by Life-Tech Intl., 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 1995-06-13.
- Submission: K946108
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.1800
- Decision date: 1995-06-13
Classification & Regulation
This clearance is catalogued under FDA product code KHH and 21 CFR 874.1800, within the Ear, Nose, Throat review panel as a Class I device.