JMS APHERESIS NEEDLE SET WINGEATER(R) V2

JMS APHERESIS NEEDLE SET WINGEATER(R) V2 is an FDA 510(k)-cleared medical device (K112178) manufactured by JMS North America Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2011. Regulation: 8.