Clearance Summary
RELIANCE TREATMENT CABINET received FDA 510(k) clearance under submission number K843046, sponsored by F. & F. Koenigkramer. 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 1984-09-27.
- Submission: K843046
- Applicant / Sponsor: F. & F. Koenigkramer
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5300
- Decision date: 1984-09-27
Classification & Regulation
This clearance is catalogued under FDA product code ETF and 21 CFR 874.5300, within the Ear, Nose, Throat review panel as a Class I device.