510(k) K210810

Steiking Packaging for Medical Devices by Wipak OY — Product Code FRG

K210810 is an FDA 510(k) premarket notification submitted by Wipak OY for the device "Steiking Packaging for Medical Devices". The FDA issued a decision of Substantially Equivalent on January 23, 2022. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Wipak OY has at least 6 other 510(k) clearances on record.