The following data is part of a premarket notification filed by Dermatron Corp. with the FDA for Uva Phototherapy System.
Device ID | K761094 |
510k Number | K761094 |
Device Name: | UVA PHOTOTHERAPY SYSTEM |
Classification | Cabinet, Phototherapy (puva) |
Applicant | DERMATRON CORP. 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 | 1976-11-23 |
Decision Date | 1976-12-02 |