TOPICAL HYPERBARIC OXYGEN CHAMBER

TOPICAL HYPERBARIC OXYGEN CHAMBER is an FDA 510(k)-cleared medical device (K861593) manufactured by Stephenson Industries, 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 May 11, 1986. Regulation: 8.