The following data is part of a premarket notification filed by Ultralite with the FDA for Psoralite.
Device ID | K761179 |
510k Number | K761179 |
Device Name: | PSORALITE |
Classification | Light, Ultraviolet, Dermatological |
Applicant | ULTRALITE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-02 |
Decision Date | 1977-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PSORALITE 73053889 1045343 Dead/Expired |
THOMAS C. ELDER, INC. 1975-06-02 |