510(k) K102971

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK by Microtek Medical, Inc. — Product Code FYA

K102971 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK". The FDA issued a decision of Substantially Equivalent on February 23, 2011. 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.