SYDNEY IVF PVP

SYDNEY IVF PVP is an FDA 510(k)-cleared medical device (K031304) manufactured by Cook Urological, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 2004. Regulation: 8.