Clearance Summary
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS received FDA 510(k) clearance under submission number K961593, sponsored by Segi Hearing Aid Co.. 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 1996-11-07.
- Submission: K961593
- Applicant / Sponsor: Segi Hearing Aid Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1996-11-07
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.