Clearance Summary
INJECTOR received FDA 510(k) clearance under submission number K023737, sponsored by Anton Meyer & Co. , 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 2003-07-14.
- Submission: K023737
- Applicant / Sponsor: Anton Meyer & Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2003-07-14
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.