Clearance Summary
RELINER FOR HEARING AID EARMOLDS received FDA 510(k) clearance under submission number K820185, sponsored by Aid-To-Hearing Corp.. 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 1982-04-09.
- Submission: K820185
- Applicant / Sponsor: Aid-To-Hearing Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1982-04-09
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.