Clearance Summary
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC received FDA 510(k) clearance under submission number K891247, sponsored by Siemens Hearing Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-03-29.
- Submission: K891247
- Applicant / Sponsor: Siemens Hearing Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3500
- Decision date: 1989-03-29
Classification & Regulation
This clearance is catalogued under FDA product code ESF and 21 CFR 878.3500, within the General, Plastic Surgery review panel as a Class II device.