510(k) K961563 ยท FDF Colonoscope And Accessories, Flexible/Rigid
EC-384OTL, VIDEO COLONSCOPE
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Jun 19, 1996 |
| Received | Apr 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961563
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.