510(k) K945371

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS by Standard Textile Co., Inc. — Product Code FYA

K945371 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on April 27, 1995. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.