The following data is part of a premarket notification filed by Sunfire Industries Inc. with the FDA for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12r Tanning Canopy.
| Device ID | K152423 |
| 510k Number | K152423 |
| Device Name: | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy |
| Classification | Booth, Sun Tan |
| Applicant | Sunfire Industries Inc. 4905 Highway 70 East New Bern, NC 28562 |
| Contact | Doug Tyler |
| Correspondent | Greg Bender Bender & Bender Project Management Services LLC 3678 Gould Dr Carmel, IN 46033 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-05-20 |
| Summary: | summary |