STRATASYS FDM MEDMODELER SYSTEM

STRATASYS FDM MEDMODELER SYSTEM is an FDA 510(k)-cleared medical device (K971290) manufactured by Paladin Medical, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 1997. Regulation: 8.