PREBYPASS FILTER, CAT. NO. FPB-5

PREBYPASS FILTER, CAT. NO. FPB-5 is an FDA 510(k)-cleared medical device (K900672) manufactured by American Omni Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 1990. Regulation: 8.