510(k) K791898

OCUTOME MODEL 8000 by Cooper Medical Devices Corp. — Product Code HKP

K791898 is an FDA 510(k) premarket notification submitted by Cooper Medical Devices Corp. for the device "OCUTOME MODEL 8000". The FDA issued a decision of Substantially Equivalent on October 30, 1979. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. Cooper Medical Devices Corp. has at least 6 other 510(k) clearances on record.