The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Solar Tone.
| Device ID | K802304 |
| 510k Number | K802304 |
| Device Name: | SOLAR TONE |
| Classification | Booth, Sun Tan |
| Applicant | BLOOMEX INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-12-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOLAR TONE 87404032 not registered Dead/Abandoned |
Brad Wilkinson 2017-04-08 |