510(k) K061308

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N by Cardinal Health 200, Inc. — Product Code FYA

K061308 is an FDA 510(k) premarket notification submitted by Cardinal Health 200, Inc. for the device "TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N". The FDA issued a decision of Substantially Equivalent on June 5, 2006. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health 200, Inc. has at least 3 other 510(k) clearances on record.