510(k) K162362

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS — Product Code FRG

K162362 is an FDA 510(k) premarket notification submitted by Pms Tibbi Cihazlar Teknolojisi San VE Tic AS for the device "PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator". The FDA issued a decision of Substantially Equivalent on Oct 13, 2017. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.