510(k) K141693

Tyvek® Pouch/Roll with STERRAD® Chemical Indicator by Advanced Sterilization Products — Product Code FRG

K141693 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "Tyvek® Pouch/Roll with STERRAD® Chemical Indicator". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.