510(k) K852575
- Device
- WALDMANN F85/100W PUVA
- Applicant
- SYLVANIA LIGHTING PRODUCTS
- 510(k) number
- K852575
- Product code
- KGL
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 1985-08-16
- Date received
- 1985-06-18
- Regulation
- 878.4630
- Classification name
- Cabinet, Phototherapy (puva)
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GWARREN J FIELD
- Address
- 100 Endicott St. Danvers MA US 01923 01923
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KGL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K841795 | UV 8001K, PUVA 800, PUVA 180/200 1000 | Waldmann Lighting Co. | 1984-08-30 |
| K820280 | SPECTRA 305/350 | Ultralite | 1982-03-05 |
| K810668 | HO-B-LITE VI UNIT | National Biological Corp. | 1981-04-23 |
| K810358 | PHOTOTHERAPY LIGHT CHAMBER | Paul B. Elder Co. | 1981-03-20 |
| K791977 | PSORALITE MARK I | Paul B. Elder Co. | 1979-12-28 |
| K791116 | PSORALITE SERIES 30,000 | Paul B. Elder Co. | 1979-09-04 |
| K761094 | UVA PHOTOTHERAPY SYSTEM | Dermatron Corp. | 1976-12-02 |
Legacy Summary#
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FDA Review#
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