510(k) K103061

BIOMATE STERILE ACUPUNCTURE NEEDLE by Biomate Medical Devices Technology Co., Ltd. — Product Code MQX

K103061 is an FDA 510(k) premarket notification submitted by Biomate Medical Devices Technology Co., Ltd. for the device "BIOMATE STERILE ACUPUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on June 20, 2011. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. Biomate Medical Devices Technology Co., Ltd. has at least 2 other 510(k) clearances on record.