510(k) K111535

EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER by Exact Medical Manufacturing, Inc. — Product Code FYA

K111535 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing, Inc. for the device "EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER". The FDA issued a decision of Substantially Equivalent on August 26, 2011. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Exact Medical Manufacturing, Inc. has at least 8 other 510(k) clearances on record.