Clearance Summary
Nix Ultra Lice Treatment Kit received FDA 510(k) clearance under submission number K163401, sponsored by Medtech Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-03-21.
- Submission: K163401
- Applicant / Sponsor: Medtech Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5960
- Decision date: 2017-03-21
Classification & Regulation
This clearance is catalogued under FDA product code LJL and 21 CFR 880.5960, within the General Hospital review panel as a Class I device.