510(k) K023266

PRIMAGARD SURGICAL GOWNS by Primeline Medical Products, Inc. — Product Code FYA

K023266 is an FDA 510(k) premarket notification submitted by Primeline Medical Products, Inc. for the device "PRIMAGARD SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on November 8, 2002. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Primeline Medical Products, Inc. has at least 8 other 510(k) clearances on record.