510(k) K143637

U&U Sterilization Pouch and Roll by U&U Medical Technology Co, Ltd. — Product Code FRG

K143637 is an FDA 510(k) premarket notification submitted by U&U Medical Technology Co, Ltd. for the device "U&U Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on Sep 9, 2015. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. U&U Medical Technology Co, Ltd. has 9 other 510(k) clearances on record.