510(k) K884961

ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL by Bausch & Lomb Pharmaceutical, Inc. — Product Code MOE

K884961 is an FDA 510(k) premarket notification submitted by Bausch & Lomb Pharmaceutical, Inc. for the device "ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL". The FDA issued a decision of Substantially Equivalent on February 13, 1989. 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.