Clearance Summary
MIRROR WARMER received FDA 510(k) clearance under submission number K781750, sponsored by Arleton Technical Products, 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 1979-01-17.
- Submission: K781750
- Applicant / Sponsor: Arleton Technical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1979-01-17
Classification & Regulation
This clearance is catalogued under FDA product code KAI and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.