510(k) K011831 ยท DWM Apparatus, Suction, Patient Care
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
| Applicant | Denver Biomedical, Inc., Golden CO, US |
| Decision | Substantially Equivalent, Jun 28, 2001 |
| Received | Jun 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011831
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.