FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UVA HEX UNIT
K Number: K813307
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
4
Review Days
38
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Basic Information
- Device Name
- UVA HEX UNIT
- K Number
- K813307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sun Shanty, Inc.
- Date Received
- November 23, 1981
- Decision Date
- December 31, 1981
- Product Code
- FTC
- 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | FDA class 2 | General, Plastic Surgery |
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