The following data is part of a premarket notification filed by Dermatron Corp. with the FDA for Lamp, Flourescent Black, High Output.
Device ID | K760471 |
510k Number | K760471 |
Device Name: | LAMP, FLOURESCENT BLACK, HIGH OUTPUT |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DERMATRON CORP. 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 | 1976-08-19 |
Decision Date | 1976-09-15 |