PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH

PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH is an FDA 510(k)-cleared medical device (K862098) manufactured by Hall/Mccollum Laboratories, Inc.. 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 November 11, 1986. Regulation: 8.