The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Ho-b-lite Vi Unit.
| Device ID | K810668 |
| 510k Number | K810668 |
| Device Name: | HO-B-LITE VI UNIT |
| Classification | Cabinet, Phototherapy (puva) |
| Applicant | NATIONAL BIOLOGICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGL |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-12 |
| Decision Date | 1981-04-23 |