510(k) K180417

Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use by Berpu Medical Technology Co., Ltd. — Product Code MEG

K180417 is an FDA 510(k) premarket notification submitted by Berpu Medical Technology Co., Ltd. for the device "Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use". The FDA issued a decision of Substantially Equivalent on August 9, 2018. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Berpu Medical Technology Co., Ltd. has at least 8 other 510(k) clearances on record.