510(k) K113033 ยท CAF Nebulizer (Direct Patient Interface)
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
| Applicant | Nephron Pharmaceuticals Corp., Orlando FL, US |
| Decision | Substantially Equivalent, Jun 19, 2012 |
| Received | Oct 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113033
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.