510(k) K950956

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE by Bio-Vascular, Inc. — Product Code GXQ

K950956 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.