Clearance Summary
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 received FDA 510(k) clearance under submission number K003036, sponsored by Retinalabs.Com. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-12-22.
- Submission: K003036
- Applicant / Sponsor: Retinalabs.Com
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4360
- Decision date: 2000-12-22
Classification & Regulation
This clearance is catalogued under FDA product code KYG and 21 CFR 886.4360, within the Ophthalmic review panel as a Class I device.