Clearance Summary
GY-RO SAFE received FDA 510(k) clearance under submission number K883785, sponsored by Gy-Ro Industry, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-01-05.
- Submission: K883785
- Applicant / Sponsor: Gy-Ro Industry, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4070
- Decision date: 1989-01-05
Classification & Regulation
This clearance is catalogued under FDA product code HOG and 21 CFR 886.4070, within the Ophthalmic review panel as a Class I device.