510(k) K120051

SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML by Nephron Pharmaceuticals Corp. — Product Code CAF

K120051 is an FDA 510(k) premarket notification submitted by Nephron Pharmaceuticals Corp. for the device "SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML". The FDA issued a decision of Substantially Equivalent on April 20, 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.