Clearance Summary
MID LABS TWIN ILLUMINATOR received FDA 510(k) clearance under submission number K932131, sponsored by Medical Instrument Development Laboratories, 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 1994-04-01.
- Submission: K932131
- Applicant / Sponsor: Medical Instrument Development Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1994-04-01
Classification & Regulation
This clearance is catalogued under FDA product code EQH and 21 CFR 874.4350, within the Ear, Nose, Throat review panel as a Class I device.