510(k) K930438

MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS by Marco Ophthalmic, Inc. — Product Code HJO

K930438 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS". The FDA issued a decision of Substantially Equivalent on August 9, 1993. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.