510(k) K061039

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE by Amsino International, Inc. — Product Code FMF

K061039 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE". The FDA issued a decision of Substantially Equivalent on June 29, 2006. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Amsino International, Inc. has at least 10 other 510(k) clearances on record.