510(k) K944061 ยท GZL Electrode, Depth
CUEVA CRANIAL NERVE ELECTRODE
| Applicant | Ad-Tech Medical Instrument Corp, Racine WI, US |
| Decision | Substantially Equivalent, Jan 20, 1995 |
| Received | Aug 19, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2014 | Ad-Tech Medical Instrument Corporation Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX .
Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Ele Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.