510(k) K113587

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

K113587 is an FDA 510(k) premarket notification submitted by Shantou Wealy Medical Instrument Co.,Ltd for the device "AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)". The FDA issued a decision of Substantially Equivalent on February 24, 2012. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shantou Wealy Medical Instrument Co.,Ltd has at least 5 other 510(k) clearances on record.