510(k) K900929

PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL by Oculo Plastik, Inc. — Product Code HQX

K900929 is an FDA 510(k) premarket notification submitted by Oculo Plastik, Inc. for the device "PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL". The FDA issued a decision of Substantially Equivalent on May 18, 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.