ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000

ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 is an FDA 510(k)-cleared medical device (K852114) manufactured by Ars 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 September 26, 1985. Regulation: 8.