510(k) K022480

ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC by Acmi Corporation — Product Code HIH

K022480 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC". The FDA issued a decision of Substantially Equivalent on August 22, 2002. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Acmi Corporation has at least 10 other 510(k) clearances on record.