MYELOTEC MYELOSCOPE

MYELOTEC MYELOSCOPE is an FDA 510(k)-cleared medical device (K960194) manufactured by Myelotec, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1996. Regulation: 8.