510(k) K972778 ยท CAF Nebulizer (Direct Patient Interface)
DEY VIAL SODIUM CHLORIDE 3%
| Applicant | Dey Laboratories, Inc., Napa CA, US |
| Decision | Substantially Equivalent, Oct 8, 1997 |
| Received | Jul 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972778
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.