FDA 510(k) Applications Submitted by SPECTRA MEDICAL DEVICES, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K151069 04/21/2015 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle SPECTRA MEDICAL DEVICES, INC.
K082580 09/05/2008 SPECTRA GUIDEWIRE INTRODUCER NEEDLE SPECTRA MEDICAL DEVICES, INC.
K082689 09/15/2008 STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE SPECTRA MEDICAL DEVICES, INC.
K103740 12/22/2010 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE SPECTRA MEDICAL DEVICES, INC.
K081524 06/02/2008 SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L SPECTRA MEDICAL DEVICES, INC.
K082674 09/15/2008 SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE SPECTRA MEDICAL DEVICES, INC.


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