510(k) K822599

KEATES I/A SYSTEM FRIGITRONICS 4000 by Frigitronics of Connecticut, Inc. — Product Code HKP

K822599 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "KEATES I/A SYSTEM FRIGITRONICS 4000". The FDA issued a decision of Substantially Equivalent on October 6, 1982. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-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.