SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR

SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR is an FDA 510(k)-cleared medical device (K925075) 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 June 6, 1993. Regulation: 8.