Clearance Summary
FLUORESCENCE ILLUMINATOR ACCESSORY received FDA 510(k) clearance under submission number K770652, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1977-07-06.
- Submission: K770652
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3600
- Decision date: 1977-07-06
Classification & Regulation
This clearance is catalogued under FDA product code IBK and 21 CFR 864.3600, within the Pathology review panel as a Class I device.