The following data is part of a premarket notification filed by Medtek Lighting with the FDA for Uv Biotek Single Panel, Uv Biotek Multi-directional.
| Device ID | K134009 |
| 510k Number | K134009 |
| Device Name: | UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | MEDTEK LIGHTING 2424 DEMPSTER DRIVE Coralville, IA 52241 |
| Contact | Susan Anthoney-de Wet |
| Correspondent | Susan Anthoney-de Wet MEDTEK LIGHTING 2424 DEMPSTER DRIVE Coralville, IA 52241 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B343MD3 | K134009 | 000 |
| B343B80 | K134009 | 000 |
| B343B60 | K134009 | 000 |
| B343B40 | K134009 | 000 |
| B343B20 | K134009 | 000 |
| B343B100 | K134009 | 000 |