510(k) K880740

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE by Spectramed, Inc. — Product Code DQF

K880740 is an FDA 510(k) premarket notification submitted by Spectramed, Inc. for the device "MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE". The FDA issued a decision of Substantially Equivalent on March 22, 1988. The device falls under product code DQF (Actuator, Syringe, Injector Type), a Class II device regulated under 21 CFR 870.1670. Spectramed, Inc. has at least 10 other 510(k) clearances on record.