510(k) K853207 ยท KOD Catheter, Urological
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
| Applicant | American Pharmaseal Div. Ahsc, Valencia CA, US |
| Decision | Substantially Equivalent, Sep 12, 1985 |
| Received | Jul 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853207
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.