The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Ml24000 Uva-1 Phototherapy Cabinet.
| Device ID | K082731 |
| 510k Number | K082731 |
| Device Name: | ML24000 UVA-1 PHOTOTHERAPY CABINET |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Contact | Tara Mansur |
| Correspondent | Tara Mansur 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 | 2008-09-18 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B280935ML240000 | K082731 | 000 |