510(k) K931144

STERILE SURGEON'S GOWN, MODIFICATION by Amsco Sterile Recoveries, Inc. — Product Code FYA

K931144 is an FDA 510(k) premarket notification submitted by Amsco Sterile Recoveries, Inc. for the device "STERILE SURGEON'S GOWN, MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Amsco Sterile Recoveries, Inc. has at least 10 other 510(k) clearances on record.