The following data is part of a premarket notification filed by Medtek Lighting Corporation with the FDA for Uvbiotek Models 3200b And 4000b.
| Device ID | K051330 |
| 510k Number | K051330 |
| Device Name: | UVBIOTEK MODELS 3200B AND 4000B |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | MEDTEK LIGHTING CORPORATION 2840 SCHERER DRIVE N. Saint Petersburg, FL 33716 |
| Contact | Robert T Wagner |
| Correspondent | Robert T Wagner MEDTEK LIGHTING CORPORATION 2840 SCHERER DRIVE N. Saint Petersburg, FL 33716 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B343B4000 | K051330 | 000 |
| B343B3200 | K051330 | 000 |