MEMOGRAPH STAPLE, WARM SYSTEM

MEMOGRAPH STAPLE, WARM SYSTEM is an FDA 510(k)-cleared medical device (K993714) manufactured by Biomedical Ent., 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 February 24, 2000. Regulation: 8.