The following data is part of a premarket notification filed by Medtech Products Inc. with the FDA for Nix Ultra Lice Treatment Kit.
| Device ID | K163401 |
| 510k Number | K163401 |
| Device Name: | Nix Ultra Lice Treatment Kit |
| Classification | Detectors And Removers, Lice, (including Combs) |
| Applicant | MEDTECH PRODUCTS INC. 660 WHITE PLAINS ROAD Tarrytown, NY 10591 |
| Contact | Jean Boyko |
| Correspondent | Vincent Argiro PRESTIGE BRANDS HOLDINGS 660 WHITE PLAINS ROAD Tarrytown, NY 10591 |
| Product Code | LJL |
| CFR Regulation Number | 880.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-03-21 |
| Summary: | summary |