510(k) K082674

SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE by Spectra Medical Devices, Inc. — Product Code FMF

K082674 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices, Inc. for the device "SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE". The FDA issued a decision of Substantially Equivalent on November 28, 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.