BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY

BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY is an FDA 510(k)-cleared medical device (K132097) manufactured by Best Medical International, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2013. Regulation: 8.