FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UV 8001K, PUVA 800, PUVA 180/200 1000
K Number: K841795
·
Decision Aug 30, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
7
Applicant Total
1
Review Days
120
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Basic Information
- Device Name
- UV 8001K, PUVA 800, PUVA 180/200 1000
- K Number
- K841795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Waldmann Lighting Co.
- Date Received
- May 2, 1984
- Decision Date
- August 30, 1984
- Product Code
- KGL
- 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 |
|---|---|---|---|
| KGL | Cabinet, Phototherapy (Puva) | FDA class 2 | General, Plastic Surgery |
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