SYDNEY IVF SPERM CRYOPRESERVATION BUFFER

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER is an FDA 510(k)-cleared medical device (K061371) 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 August 16, 2006. Regulation: 8.