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 |