Clearance Summary
KOWA NONMYD ALPHA-DIII received FDA 510(k) clearance under submission number K082767, sponsored by Kowa Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-10-21.
- Submission: K082767
- Applicant / Sponsor: Kowa Co. , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1120
- Decision date: 2008-10-21
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.