510(k) K914529

SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS by Oasis Medical, Inc. — Product Code MOE

K914529 is an FDA 510(k) premarket notification submitted by Oasis Medical, Inc. for the device "SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS". The FDA issued a decision of Substantially Equivalent on November 13, 1991. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Oasis Medical, Inc. has at least 10 other 510(k) clearances on record.