MICROFLO-SAFE SCALP VEIN SET

MICROFLO-SAFE SCALP VEIN SET is an FDA 510(k)-cleared medical device (K043328) manufactured by Dks Loversan Industria Biomedica Spa. 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 April 14, 2005. Regulation: 8.