Clearance Summary
Resultz Lice & Egg Removal Kit received FDA 510(k) clearance under submission number K151562, sponsored by Piedmont Pharmaceuticals, LLC. 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 2017-05-08.
- Submission: K151562
- Applicant / Sponsor: Piedmont Pharmaceuticals, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5960
- Decision date: 2017-05-08
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.