Lice Removal Kit Containing A Solution
The Lice Removal Kit Containing A Solution is a general hospital device used to remove lice eggs (nits) from hair, typically consisting of a specialized fine-toothed comb and a conditioning or loosening solution to facilitate mechanical removal of nits. It is classified as FDA Class I under regulation 21 CFR 880.5960, subject only to general controls and exempt from the premarket notification (510(k)) requirement. The product code is PUN and it falls under the General Hospital medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUN
- Device Class
- FDA class 1
- Regulation Number
- 880.5960
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
To remove lice eggs from hair
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.