510(k) K071886

SELF SEAL STERILIZATION POUCH by Shanghai Jianzhong Medical Packaging Co., Ltd. — Product Code FRG

K071886 is an FDA 510(k) premarket notification submitted by Shanghai Jianzhong Medical Packaging Co., Ltd. for the device "SELF SEAL STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on December 27, 2007. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Shanghai Jianzhong Medical Packaging Co., Ltd. has at least 2 other 510(k) clearances on record.