510(k) K973552

OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP by Bio-Vascular, Inc. — Product Code MTZ

K973552 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code MTZ (Wrap, Implant, Orbital), a Class II device regulated under 21 CFR 886.3320. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.