510(k) K113033

SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML by Nephron Pharmaceuticals Corp. — Product Code CAF

K113033 is an FDA 510(k) premarket notification submitted by Nephron Pharmaceuticals Corp. for the device "SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML". The FDA issued a decision of Substantially Equivalent on June 19, 2012. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Nephron Pharmaceuticals Corp. has at least 1 other 510(k) clearance on record.