Clearance Summary
BINOCULAR OPERATING MICROSCOPES & received FDA 510(k) clearance under submission number K822012, sponsored by Kelleher Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1982-07-30.
- Submission: K822012
- Applicant / Sponsor: Kelleher Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4125
- Decision date: 1982-07-30
Classification & Regulation
This clearance is catalogued under FDA product code HBN and 21 CFR 882.4125, within the Neurology review panel as a Class I device.