510(k) K043369

CERVEX-BRUSH COMBI by Rovers Medical Devices B.V. — Product Code HHT

K043369 is an FDA 510(k) premarket notification submitted by Rovers Medical Devices B.V. for the device "CERVEX-BRUSH COMBI". The FDA issued a decision of Substantially Equivalent on February 2, 2005. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Rovers Medical Devices B.V. has at least 2 other 510(k) clearances on record.