FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LOUSEBUSTER
K Number: K093144
·
Decision Dec 16, 2009
Classifications
1
FEI Numbers
47
Registration Numbers
48
Same Product Code
10
Applicant Total
2
Review Days
72
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Basic Information
- Device Name
- LOUSEBUSTER
- K Number
- K093144
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Larada Sciences
- Date Received
- October 5, 2009
- Decision Date
- December 16, 2009
- 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 |
Similar 510(k) Clearances
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Other Clearances by Larada Sciences
| K Number | Device Name | ||
|---|---|---|---|
| K083206 | LOUSEBUSTER | Mar 10, 2009 | Substantially Equivalent |