FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMABRADER
K Number: K905046
·
Decision Dec 19, 1990
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
1
Applicant Total
46
Review Days
41
Basic Information
- Device Name
- DERMABRADER
- K Number
- K905046
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- AARON MEDICAL INDUSTRIES
- Date Received
- November 8, 1990
- Decision Date
- December 19, 1990
- Product Code
- GFE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GFE | Brush, Dermabrasion, Powered | FDA class 1 | General, Plastic Surgery |
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