NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS

NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS is an FDA 510(k)-cleared medical device (K911227) manufactured by 3M Health Care, Sarns. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 1991. Regulation: 8.