510(k) K142153 ยท CAF Nebulizer (Direct Patient Interface)
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
| Applicant | Teleflexmedical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 29, 2015 |
| Received | Aug 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2023 | MEDLINE INDUSTRIES, LP - Northfield HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U Open, Classified |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.