HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) is an FDA 510(k)-cleared medical device (K101547) manufactured by Henke-Sass, Wolf GmbH. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2010. Regulation: 8.