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 |