SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM

SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM is an FDA 510(k)-cleared medical device (K112644) manufactured by Lotus Bio, Ltd.. 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 December 18, 2012. Regulation: 8.