510(k) K970598 ยท FCW Light Source, Fiberoptic, Routine
INTEGRATED VISUALIZATION SYSTEM
| Applicant | Urohealth, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Mar 12, 1997 |
| Received | Feb 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970598
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.