510(k) K192147

Halyard ONE-STEP* Sterilization Wrap by Owens & Minor (O&M) Halyard, Inc. — Product Code FRG

K192147 is an FDA 510(k) premarket notification submitted by Owens & Minor (O&M) Halyard, Inc. for the device "Halyard ONE-STEP* Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on October 10, 2019. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Owens & Minor (O&M) Halyard, Inc. has at least 10 other 510(k) clearances on record.