510(k) K130091 ยท CAF Nebulizer (Direct Patient Interface)
PULMOSAL
| Applicant | Pharmacaribe, Bonita Springs FL, US |
| Decision | Substantially Equivalent, Mar 13, 2013 |
| Received | Jan 15, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2016 | Pharmacaribe llc PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4
For Inhalation Only Rx
Product Usage:
The contents of these vials are used in con Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.