510(k) K193561

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch by Weihai Xingtai Packaging Products Co., Ltd. — Product Code FRG

K193561 is an FDA 510(k) premarket notification submitted by Weihai Xingtai Packaging Products Co., Ltd. for the device "Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch". The FDA issued a decision of Substantially Equivalent on Apr 15, 2020. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Weihai Xingtai Packaging Products Co., Ltd. has 1 other 510(k) clearance on record.