510(k) K031053 ยท EGJ Device, Iontophoresis, Other Uses
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
| Applicant | Selectivemed Components, Inc., Mount Vernon OH, US |
| Decision | Substantially Equivalent, May 20, 2003 |
| Received | Apr 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2005 | Selectivemed Components Inc Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, Terminated |
EGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.