510(k) K003036

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 by Retinalabs.Com — Product Code KYG

K003036 is an FDA 510(k) premarket notification submitted by Retinalabs.Com for the device "TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025". The FDA issued a decision of Substantially Equivalent on December 22, 2000. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Retinalabs.Com has at least 4 other 510(k) clearances on record.