510(k) K013597 ยท KNA Instrument, Manual, Specialized Obstetric-Gynecologic
TAMPONADE UTERINE BALLOON CATHETER SET
| Applicant | Cook Ob/Gyn, Spencer IN, US |
| Decision | Substantially Equivalent, Apr 17, 2002 |
| Received | Oct 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013597
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.