LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL

LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL is an FDA 510(k)-cleared medical device (K884364) manufactured by Bausch & Lomb Pharmaceutical, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 28, 1988. Regulation: 8.