Clearance Summary
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT received FDA 510(k) clearance under submission number K991958, sponsored by Kiel Laboratories, 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 1999-08-13.
- Submission: K991958
- Applicant / Sponsor: Kiel Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5960
- Decision date: 1999-08-13
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.