SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE

SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE is an FDA 510(k)-cleared medical device (K103740) manufactured by Spectra Medical Devices, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2011. Regulation: 8.