510(k) K853457

COBURN I/A SYSTEM by Coburn Optical Ind., Inc. — Product Code HQE

K853457 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "COBURN I/A SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 1985. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.