NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600

NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 is an FDA 510(k)-cleared medical device (K935862) manufactured by Northgate Technologies, 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 18, 1994. Regulation: 8.