510(k) K141712

KIMGUARD ONE STEP STERILIZATION WRAP by Halyard Health — Product Code FRG

K141712 is an FDA 510(k) premarket notification submitted by Halyard Health for the device "KIMGUARD ONE STEP STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Halyard Health has at least 10 other 510(k) clearances on record.