DAUM MRI/CONVENTIONAL BIOPSY KIT

DAUM MRI/CONVENTIONAL BIOPSY KIT is an FDA 510(k)-cleared medical device (K991366) manufactured by Daum GmbH. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 1999. Regulation: 8.