The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 4 Series Phototherapy Unit Model 4 Series.
| Device ID | K111172 |
| 510k Number | K111172 |
| Device Name: | 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-26 |
| Decision Date | 2011-08-29 |
| Summary: | summary |