510(k) K233262

Dukal SMS Sterilization Wrap by Dukal, LLC — Product Code FRG

K233262 is an FDA 510(k) premarket notification submitted by Dukal, LLC for the device "Dukal SMS Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Dukal, LLC has at least 10 other 510(k) clearances on record.