510(k) K964131 ยท FAM Sigmoidoscope And Accessories, Flexible/Rigid
ENDOSCOPE
| Applicant | Akos Biomedical, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964131
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.