510(k) K133189

DUAL SHOT ALPHA 7 by Nemoto Kyorindo Co., Ltd. — Product Code DXT

K133189 is an FDA 510(k) premarket notification submitted by Nemoto Kyorindo Co., Ltd. for the device "DUAL SHOT ALPHA 7". The FDA issued a decision of Substantially Equivalent on June 30, 2014. 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.