SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET

SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET is an FDA 510(k)-cleared medical device (K963355) manufactured by Solopak Medical Products, Inc.. 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 October 3, 1996. Regulation: 8.