Clearance Summary
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE received FDA 510(k) clearance under submission number K861749, sponsored by Keeler Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1986-05-23.
- Submission: K861749
- Applicant / Sponsor: Keeler Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-05-23
Classification & Regulation
This clearance is catalogued under FDA product code FSP and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.