MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE

MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE is an FDA 510(k)-cleared medical device (K934011) manufactured by Neward Enterprises, 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 May 3, 1994. Regulation: 8.