FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Nix Ultra Lice Treatment Kit
K Number: K163401
·
Decision Mar 21, 2017
Classifications
1
FEI Numbers
47
Registration Numbers
48
Same Product Code
10
Applicant Total
9
Review Days
106
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Basic Information
- Device Name
- Nix Ultra Lice Treatment Kit
- K Number
- K163401
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtech Products, Inc.
- Date Received
- December 5, 2016
- Decision Date
- March 21, 2017
- Product Code
- LJL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LJL | Detectors And Removers, Lice, (Including Combs) | FDA class 1 | General Hospital |
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