510(k) K240330

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

K240330 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)". The FDA issued a decision of Substantially Equivalent on August 7, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. O&M Halyard, Inc. has at least 10 other 510(k) clearances on record.