510(k) K901002

O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES by Oculo Plastik, Inc. — Product Code HQX

K901002 is an FDA 510(k) premarket notification submitted by Oculo Plastik, Inc. for the device "O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES". The FDA issued a decision of Substantially Equivalent on May 22, 1990. The device falls under product code HQX (Implant, Orbital, Extra-Ocular), a Class II device regulated under 21 CFR 886.3340. Oculo Plastik, Inc. has at least 10 other 510(k) clearances on record.