510(k) K000902

KLINIDRAPE REINFORCED SURGICAL GOWNS by Molnlycke Health Care, Inc. — Product Code FYA

K000902 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care, Inc. for the device "KLINIDRAPE REINFORCED SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on July 11, 2000. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Molnlycke Health Care, Inc. has at least 10 other 510(k) clearances on record.