510(k) K971920

GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) by Customed, Inc. — Product Code FYA

K971920 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)". The FDA issued a decision of Substantially Equivalent on December 4, 1997. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Customed, Inc. has at least 10 other 510(k) clearances on record.