K163401 is an FDA 510(k) clearance for the Nix Ultra Lice Treatment Kit. This device is classified as a Detectors And Removers, Lice, (including Combs) (Class I - General Controls, product code LJL).
Submitted by Medtech Products, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 21, 2017, 106 days after receiving the submission on December 5, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5960.
| 510(k) Number | K163401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2016 |
| Decision Date | March 21, 2017 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJL - Detectors And Removers, Lice, (including Combs) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5960 |