Clearance Summary
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 received FDA 510(k) clearance under submission number K852150, 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 1985-06-03.
- Submission: K852150
- Applicant / Sponsor: Keeler Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4700
- Decision date: 1985-06-03
Classification & Regulation
This clearance is catalogued under FDA product code HRM and 21 CFR 878.4700, within the General, Plastic Surgery review panel as a Class I device.