The following data is part of a premarket notification filed by Waldmann Lighting Co. with the FDA for Uv 8001k, Puva 800, Puva 180/200 1000.
| Device ID | K841795 |
| 510k Number | K841795 |
| Device Name: | UV 8001K, PUVA 800, PUVA 180/200 1000 |
| Classification | Cabinet, Phototherapy (puva) |
| Applicant | WALDMANN LIGHTING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGL |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-02 |
| Decision Date | 1984-08-30 |