510(k) K884363

LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL by Bausch & Lomb Pharmaceutical, Inc. — Product Code MOE

K884363 is an FDA 510(k) premarket notification submitted by Bausch & Lomb Pharmaceutical, Inc. for the device "LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL". The FDA issued a decision of Substantially Equivalent on November 29, 1988. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Bausch & Lomb Pharmaceutical, Inc. has at least 5 other 510(k) clearances on record.