The following data is part of a premarket notification filed by Medfaxx, Inc. with the FDA for Birtcher Uv Lamp.
| Device ID | K973865 |
| 510k Number | K973865 |
| Device Name: | BIRTCHER UV LAMP |
| Classification | Lamp, Uvc, (for Treating Skin And Wounds) |
| Applicant | MEDFAXX, INC. P.O. BOX 17827 Raleigh, NC 27619 -7827 |
| Contact | Bob Johnson |
| Correspondent | Bob Johnson MEDFAXX, INC. P.O. BOX 17827 Raleigh, NC 27619 -7827 |
| Product Code | MXG |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1999-02-26 |