Clearance Summary
BIOTOME received FDA 510(k) clearance under submission number K771711, sponsored by Berkeley Bio-Engineering. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1977-09-28.
- Submission: K771711
- Applicant / Sponsor: Berkeley Bio-Engineering
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1977-09-28
Classification & Regulation
This clearance is catalogued under FDA product code HQE and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.