510(k) K880411

DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE by Dey Laboratories, Inc. — Product Code CAF

K880411 is an FDA 510(k) premarket notification submitted by Dey Laboratories, Inc. for the device "DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Dey Laboratories, Inc. has at least 5 other 510(k) clearances on record.