The following data is part of a premarket notification filed by The Daavlin Distributing Company with the FDA for Ml24000 Uva-1 Phototherapy Unit.
| Device ID | K103708 |
| 510k Number | K103708 |
| Device Name: | ML24000 UVA-1 PHOTOTHERAPY UNIT |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | THE DAAVLIN DISTRIBUTING COMPANY 205 WEST BEMENT STREET Bryan, OH 43506 |
| Contact | Michael Thiel |
| Correspondent | Michael Thiel THE DAAVLIN DISTRIBUTING COMPANY 205 WEST 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 | 2010-12-20 |
| Decision Date | 2011-02-22 |
| Summary: | summary |