510(k) K980696

FOAM TIP INJECTOR by Staar Surgical Co. — Product Code MSS

K980696 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "FOAM TIP INJECTOR". The FDA issued a decision of Substantially Equivalent on September 11, 1998. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Staar Surgical Co. has at least 10 other 510(k) clearances on record.