The following data is part of a premarket notification filed by Ultralite with the FDA for Spectra 305/350.
| Device ID | K820280 |
| 510k Number | K820280 |
| Device Name: | SPECTRA 305/350 |
| Classification | Cabinet, Phototherapy (puva) |
| Applicant | ULTRALITE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KGL |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1982-03-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPECTRA 305/350 73368616 1288827 Dead/Cancelled |
Daavlin Distributing Company, The 1982-06-08 |