510(k) K961083

OREX SURGEON'S VEST by Thantex Specialties, Inc. — Product Code FYA

K961083 is an FDA 510(k) premarket notification submitted by Thantex Specialties, Inc. for the device "OREX SURGEON'S VEST". The FDA issued a decision of Substantially Equivalent on August 23, 1996. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Thantex Specialties, Inc. has at least 10 other 510(k) clearances on record.