PRESSURE BARRIER KIT CAT. NO. PBK-3

PRESSURE BARRIER KIT CAT. NO. PBK-3 is an FDA 510(k)-cleared medical device (K873802) 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 November 5, 1987. Regulation: 8.