SAF-T-SYRINGE/SAF-T-NEEDLE

SAF-T-SYRINGE/SAF-T-NEEDLE is an FDA 510(k)-cleared medical device (K051762) manufactured by Safety Medical International, Incorporated. 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 September 22, 2005. Regulation: 8.