510(k) K111246 ยท CAF Nebulizer (Direct Patient Interface)
SPIRALE DRUG DELIVERY SYSTEM
| Applicant | Armstrong Medical , Ltd., Coleraine, IE |
| Decision | Substantially Equivalent, Aug 10, 2012 |
| Received | May 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111246
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.