510(k) K071691

DUAL SHOT ALPHA by Nemoto Kyorindo Co., Ltd. — Product Code DXT

K071691 is an FDA 510(k) premarket notification submitted by Nemoto Kyorindo Co., Ltd. for the device "DUAL SHOT ALPHA". The FDA issued a decision of Substantially Equivalent on December 19, 2007. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Nemoto Kyorindo Co., Ltd. has at least 7 other 510(k) clearances on record.