510(k) K913148

COLLAGEN SHIELD FOR ACUTE CARE by Vitaphore Corp. — Product Code MOE

K913148 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "COLLAGEN SHIELD FOR ACUTE CARE". The FDA issued a decision of Substantially Equivalent on October 15, 1991. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Vitaphore Corp. has at least 10 other 510(k) clearances on record.