Clearance Summary
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT received FDA 510(k) clearance under submission number K941661, sponsored by Gm Engineering, 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 1994-08-23.
- Submission: K941661
- Applicant / Sponsor: Gm Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1994-08-23
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.