510(k) K082031

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES by Appasamy Associates — Product Code HJO

K082031 is an FDA 510(k) premarket notification submitted by Appasamy Associates for the device "APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES". The FDA issued a decision of Substantially Equivalent on July 31, 2008. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Appasamy Associates has at least 1 other 510(k) clearance on record.