510(k) K221379

Steriking LT-Blueline Pouches with Tyvek by Wipak OY — Product Code FRG

K221379 is an FDA 510(k) premarket notification submitted by Wipak OY for the device "Steriking LT-Blueline Pouches with Tyvek". The FDA issued a decision of Substantially Equivalent on January 4, 2023. 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.