Clearance Summary
GRIESHABER GLOBAL CONTROL TUBING SET received FDA 510(k) clearance under submission number K863444, 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 1986-10-31.
- Submission: K863444
- Applicant / Sponsor: Grieshaber & Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1986-10-31
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.