510(k) K974056 ยท CAF Nebulizer (Direct Patient Interface)
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
| Applicant | Holopack International, LP, Columbia SC, US |
| Decision | Substantially Equivalent, Jan 21, 1998 |
| Received | Oct 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974056
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.