510(k) K081524

SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L by Spectra Medical Devices, Inc. — Product Code FMF

K081524 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices, Inc. for the device "SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L". The FDA issued a decision of Substantially Equivalent on July 29, 2008. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Spectra Medical Devices, Inc. has at least 7 other 510(k) clearances on record.