Clearance Summary
ROYALE AE 9036 LSP INJECTOR received FDA 510(k) clearance under submission number K073010, sponsored by Asico, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2007-11-07.
- Submission: K073010
- Applicant / Sponsor: Asico, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2007-11-07
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.