510(k) K850694 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
WSP CODE 4310 STRESSCATH
| Applicant | Warne Surgical Products, Ltd., Armagh Bt66 8rd, IE |
| Decision | Substantially Equivalent, May 17, 1985 |
| Received | Feb 21, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850694
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.