The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Dermapal, Uva 50hz, Uva 60hz, Uvb Broad Band 50hz, Uvb Broad Band 60hz,uvb Narrow Band 50hz, Uvb Narrow Band 60hz.
| Device ID | K022104 |
| 510k Number | K022104 |
| Device Name: | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Contact | Chad Reynolds |
| Correspondent | Chad Reynolds 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 | 2002-06-28 |
| Decision Date | 2002-09-10 |
| Summary: | summary |