DOME, DISPOSABLE, STERILE

DOME, DISPOSABLE, STERILE is an FDA 510(k)-cleared medical device (K851989) manufactured by Transamerica Delaval, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 1985. Regulation: 8.