30 ML OR 60 ML PEDI-SYRINGE FILTER

30 ML OR 60 ML PEDI-SYRINGE FILTER is an FDA 510(k)-cleared medical device (K050805) manufactured by Blood Products Specialties, LLC. 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 June 19, 2005. Regulation: 8.