510(k) K832040

STERILE FLUID PRODUCING UNIT #EP550 by American Cystocope Makers, Inc. — Product Code LJH

K832040 is an FDA 510(k) premarket notification submitted by American Cystocope Makers, Inc. for the device "STERILE FLUID PRODUCING UNIT #EP550". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. American Cystocope Makers, Inc. has at least 8 other 510(k) clearances on record.