MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT

MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT is an FDA 510(k)-cleared medical device (K913324) 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 June 21, 1992. Regulation: 8.