INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS

INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS is an FDA 510(k)-cleared medical device (K952889) manufactured by Materials Conversion Corp.. 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 21, 1995. Regulation: 8.