510(k) K980829 ยท CAF Nebulizer (Direct Patient Interface)
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
| Applicant | Steripak, Ltd., Northvale NJ, US |
| Decision | Substantially Equivalent, Jun 2, 1998 |
| Received | Mar 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980829
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.