Clearance Summary
ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG received FDA 510(k) clearance under submission number K821079, sponsored by Ms. Kate Teaney. 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 1982-05-10.
- Submission: K821079
- Applicant / Sponsor: Ms. Kate Teaney
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1325
- Decision date: 1982-05-10
Classification & Regulation
This clearance is catalogued under FDA product code KLX and 21 CFR 874.1325, within the Ear, Nose, Throat review panel as a Class II device.