510(k) K181957

Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted by Tianchang Jiarui Packaging Material Co., Ltd. — Product Code FRG

K181957 is an FDA 510(k) premarket notification submitted by Tianchang Jiarui Packaging Material Co., Ltd. for the device "Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted". The FDA issued a decision of Substantially Equivalent on Jul 9, 2019. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Tianchang Jiarui Packaging Material Co., Ltd. has 1 other 510(k) clearance on record.