The following data is part of a premarket notification filed by Strato-ray Co. with the FDA for Fluorescent Sun Lamp Fixture.
Device ID | K802291 |
510k Number | K802291 |
Device Name: | FLUORESCENT SUN LAMP FIXTURE |
Classification | Lamp, Fluorescein, Ac-powered |
Applicant | STRATO-RAY CO. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | HJE |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-19 |
Decision Date | 1980-10-31 |