510(k) K170429

Tyvek Sterilization Pouches with Chevron Seal by Andersen Sterilizers, Inc. — Product Code FRG

K170429 is an FDA 510(k) premarket notification submitted by Andersen Sterilizers, Inc. for the device "Tyvek Sterilization Pouches with Chevron Seal". The FDA issued a decision of Substantially Equivalent on October 27, 2017. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Andersen Sterilizers, Inc. has at least 10 other 510(k) clearances on record.