Clearance Summary
DYNASTY HEARING SYSTEMS INSTRUMENT received FDA 510(k) clearance under submission number K900632, sponsored by Alastair Granville-Jackson, Mfa, Ed.D.. 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 1990-09-12.
- Submission: K900632
- Applicant / Sponsor: Alastair Granville-Jackson, Mfa, Ed.D.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1990-09-12
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.