510(k) K120051 ยท CAF Nebulizer (Direct Patient Interface)
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
| Applicant | Nephron Pharmaceuticals Corp., Orlando FL, US |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | Jan 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2016 | Nephron Pharmaceuticals Corp. Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60.
A vial contains sterile, preservation-free, clear, colorless, aqueous solution as Terminated |
CAF | None listed |
| Jun 27, 2016 | Nephron Pharmaceuticals Corp. Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60.
A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.