510(k) K972964 ยท KOE Dilator, Urethral
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
| Applicant | Atrion Medical Products, Inc., Arab AL, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | Aug 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972964
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.