PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR

PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR is an FDA 510(k)-cleared medical device (K994381) manufactured by Raven Biological Laboratories, 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 March 29, 2001. Regulation: 8.