SAFE MATE I.V. EXTENSION SETS

SAFE MATE I.V. EXTENSION SETS is an FDA 510(k)-cleared medical device (K962801) manufactured by Biological & Environmental Control Laboratories. 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 August 27, 1996. Regulation: 8.