The following data is part of a premarket notification filed by Paul B. Elder Co. with the FDA for Psoralite Mark I.
Device ID | K791977 |
510k Number | K791977 |
Device Name: | PSORALITE MARK I |
Classification | Cabinet, Phototherapy (puva) |
Applicant | PAUL B. ELDER 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 | 1979-10-02 |
Decision Date | 1979-12-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PSORALITE MARK I 73250846 1180973 Dead/Cancelled |
Paul B. Elder Company 1980-02-20 |