ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.

ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. is an FDA 510(k)-cleared medical device (K896134) manufactured by Goosen Enterprises, 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 August 29, 1990. Regulation: 8.