510(k) K092023

NAVIJECT SUB2-1P, MODEL: LP604430 by Medicel AG — Product Code MSS

K092023 is an FDA 510(k) premarket notification submitted by Medicel AG for the device "NAVIJECT SUB2-1P, MODEL: LP604430". The FDA issued a decision of Substantially Equivalent on July 28, 2009. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Medicel AG has at least 5 other 510(k) clearances on record.