510(k) K853308

KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 by Frigitronics of Connecticut, Inc. — Product Code HQE

K853308 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000". The FDA issued a decision of Substantially Equivalent on October 4, 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. Frigitronics of Connecticut, Inc. has at least 8 other 510(k) clearances on record.