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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2809X807QS0010CX6 | K182215 | 000 |
| 00810182930473 | K182215 | 000 |
| 00810182930480 | K182215 | 000 |
| 00810182930657 | K182215 | 000 |
| 00810182930664 | K182215 | 000 |
| 00810182930671 | K182215 | 000 |
| B2809801MI1000CX6 | K182215 | 000 |
| B2809811UV0012CX6E0 | K182215 | 000 |
| B2809811UV0016CT6E0 | K182215 | 000 |
| 00810182930466 | K182215 | 000 |