510(k) K063716 ยท CAF Nebulizer (Direct Patient Interface)
AEROSOL SYSTEM
| Applicant | Amici, Inc., Spring City PA, US |
| Decision | Substantially Equivalent, Dec 28, 2007 |
| Received | Dec 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063716
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.