The following data is part of a premarket notification filed by Daavlin Distributing Company with the FDA for 3 Series Phototherapy Unit.
| Device ID | K153749 |
| 510k Number | K153749 |
| Device Name: | 3 Series Phototherapy Unit |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN DISTRIBUTING COMPANY 205 WEST BEMENT STREET Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel DAAVLIN DISTRIBUTING COMPANY 205 WEST BEMENT STREET Bryan, OH 43506 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-29 |
| Decision Date | 2016-06-30 |
| Summary: | summary |