510(k) K070988

SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) by Shinchang Medical Co., Ltd. — Product Code FMI

K070988 is an FDA 510(k) premarket notification submitted by Shinchang Medical Co., Ltd. for the device "SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)". The FDA issued a decision of Substantially Equivalent on August 23, 2007. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Shinchang Medical Co., Ltd. has at least 2 other 510(k) clearances on record.