510(k) K062899

MICROTEK MEDICAL SURGICAL GOWN/TOGA by Microtek Medical, Inc. — Product Code FYA

K062899 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "MICROTEK MEDICAL SURGICAL GOWN/TOGA". The FDA issued a decision of Substantially Equivalent on January 25, 2007. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.