510(k) K181174

Cardinal Health Sterilization Wrap by Cardinal Health200, LLC — Product Code FRG

K181174 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Cardinal Health Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on December 11, 2018. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.