TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N is an FDA 510(k)-cleared medical device (K061308) manufactured by Cardinal Health 200, 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 June 4, 2006. Regulation: 8.