510(k) K182184

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) by Mdk (Shanghai) Medical Packing Co., Ltd. — Product Code FRG

K182184 is an FDA 510(k) premarket notification submitted by Mdk (Shanghai) Medical Packing Co., Ltd. for the device "Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)". The FDA issued a decision of Substantially Equivalent on Oct 10, 2019. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.