510(k) K181959

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) by Owens & Minor Halyard, Inc. — Product Code FRG

K181959 is an FDA 510(k) premarket notification submitted by Owens & Minor Halyard, Inc. for the device "HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)". The FDA issued a decision of Substantially Equivalent on Mar 22, 2019. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Owens & Minor Halyard, Inc. has 1 other 510(k) clearance on record.