510(k) K082939

COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 by Cook Urological, Inc. — Product Code KNA

K082939 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400". The FDA issued a decision of Substantially Equivalent on September 3, 2009. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.