510(k) K951292

PASSPORT FOLDABLE LENS PLACEMENT SYSTEM by Chiron Vision Corp. — Product Code KYB

K951292 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "PASSPORT FOLDABLE LENS PLACEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.