510(k) K970370

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE by Tsk Laboratory, Japan — Product Code FMI

K970370 is an FDA 510(k) premarket notification submitted by Tsk Laboratory, Japan for the device "TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE". The FDA issued a decision of Substantially Equivalent on April 10, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Tsk Laboratory, Japan has at least 2 other 510(k) clearances on record.