510(k) K080580 ยท EGJ Device, Iontophoresis, Other Uses
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
| Applicant | Axelgaard Mfg. Co., Ltd., Fallbrook CA, US |
| Decision | Substantially Equivalent, Jun 18, 2008 |
| Received | Mar 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080580
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.