The following data is part of a premarket notification filed by Dermatron Corp. with the FDA for Sunlamp, Flourescent Dermatron F40-313 And F20-313.
Device ID | K760519 |
510k Number | K760519 |
Device Name: | SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 |
Classification | Lamp, Infrared, Non Heating |
Applicant | DERMATRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IOB |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-26 |
Decision Date | 1976-09-03 |