PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE

PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE is an FDA 510(k)-cleared medical device (K855065) manufactured by Cobe Laboratories, Inc.. 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 February 27, 1986. Regulation: 8.