LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER

LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER is an FDA 510(k)-cleared medical device (K925430) manufactured by Douglas Medical Products Corp.. 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 2, 1993. Regulation: 8.