510(k) K000901

KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION by Molnlycke Health Care, Inc. — Product Code FYA

K000901 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care, Inc. for the device "KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION". The FDA issued a decision of Substantially Equivalent on July 5, 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.