Clearance Summary
KOWA nonmyd 8 received FDA 510(k) clearance under submission number K191945, sponsored by Kowa Company , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-09-10.
- Submission: K191945
- Applicant / Sponsor: Kowa Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2019-09-10
Classification & Regulation
This clearance is catalogued under FDA product code HKI and 21 CFR 886.1120, within the Ophthalmic review panel as a Class II device.