The following data is part of a premarket notification filed by Daavlin Distributing Company with the FDA for Clearlink Controlled Phototherapy Equipment.
| Device ID | K182215 |
| 510k Number | K182215 |
| Device Name: | ClearLink Controlled Phototherapy Equipment |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Daavlin Distributing Company 205 W. Bement Street Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel Daavlin Distributing Company 205 W. Bement Street 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 | 2018-08-15 |
| Decision Date | 2018-10-29 |
| Summary: | summary |