BUSSE ISOLATION AND PROCEDURAL MASKS

BUSSE ISOLATION AND PROCEDURAL MASKS is an FDA 510(k)-cleared medical device (K940720) manufactured by Busse Hospital Disposables, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 1994. Regulation: 8.