The following data is part of a premarket notification filed by Natus Manufacturing Limited with the FDA for Allergan Botox Needle Electrode.
| Device ID | K173815 |
| 510k Number | K173815 |
| Device Name: | Allergan Botox Needle Electrode |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | Natus Manufacturing Limited IDA Business Park Gort, IE H91 Pd92 |
| Contact | Maria Connolly |
| Correspondent | Martha Kennedy Natus Manufacturing Limited IDA Business Park Gort, IE H91 Pd92 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-06-29 |
| Summary: | summary |