510(k) K853251 ยท DTZ Oxygenator, Cardiopulmonary Bypass
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
| Applicant | Johnson & Johnson Professionals, Inc., King Of Prussia PA, US |
| Decision | Substantially Equivalent, Oct 16, 1985 |
| Received | Jul 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853251
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.