The following data is part of a premarket notification filed by National Biological Corporation with the FDA for Houva-net Control System.
| Device ID | K150912 |
| 510k Number | K150912 |
| Device Name: | Houva-NET Control System |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | National Biological Corporation 23700 Mercantile Road Beachwood, OH 44122 |
| Contact | Lynn Keller |
| Correspondent | Jennifer Cartledge REU Associates Inc. 409 Woodridge Dr. Seneca, SC 29672 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-03 |
| Decision Date | 2015-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816878020657 | K150912 | 000 |
| 00816878020459 | K150912 | 000 |
| 00816878020466 | K150912 | 000 |
| 00816878020473 | K150912 | 000 |
| 00816878020480 | K150912 | 000 |
| 00816878020497 | K150912 | 000 |
| 00816878020503 | K150912 | 000 |
| 00816878020510 | K150912 | 000 |
| 00816878020527 | K150912 | 000 |
| 00816878020534 | K150912 | 000 |
| 00816878020640 | K150912 | 000 |
| 00816878020442 | K150912 | 000 |