The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Houva 3 Phototherapy System.
| Device ID | K041212 |
| 510k Number | K041212 |
| Device Name: | HOUVA 3 PHOTOTHERAPY SYSTEM |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
| Contact | Loretta Mooney |
| Correspondent | Loretta Mooney NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816878020633 | K041212 | 000 |
| 00816878020626 | K041212 | 000 |
| 00816878020435 | K041212 | 000 |
| 00816878020428 | K041212 | 000 |
| 00816878020411 | K041212 | 000 |
| 00816878020404 | K041212 | 000 |
| 00816878020398 | K041212 | 000 |
| 00816878020381 | K041212 | 000 |