Clearance Summary
THE GRIESHABER AXIAL CUTTER received FDA 510(k) clearance under submission number K950056, sponsored by Grieshaber & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-05-05.
- Submission: K950056
- Applicant / Sponsor: Grieshaber & Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1995-05-05
Classification & Regulation
This clearance is catalogued under FDA product code HKP and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.