510(k) K152481

DURAFORM Dural Graft Implant by Codman & Shurtleff, Inc. — Product Code GXQ

K152481 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "DURAFORM Dural Graft Implant". The FDA issued a decision of Substantially Equivalent on October 30, 2015. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.