Clearance Summary
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR received FDA 510(k) clearance under submission number K862769, sponsored by Maico Hearing Instruments, 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 1986-08-13.
- Submission: K862769
- Applicant / Sponsor: Maico Hearing Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1986-08-13
Classification & Regulation
This clearance is catalogued under FDA product code LRB and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.