PERMADYNE GARANT LOW VISCOSITY

PERMADYNE GARANT LOW VISCOSITY is an FDA 510(k)-cleared medical device (K896539) manufactured by Espe GmbH (Us). This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 1990. Regulation: 8.