The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Houva Ii Uva/uvb.
| Device ID | K885029 |
| 510k Number | K885029 |
| Device Name: | HOUVA II UVA/UVB |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
| Contact | Arthur Goddard |
| Correspondent | Arthur Goddard NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1989-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816878020374 | K885029 | 000 |
| 00816878020367 | K885029 | 000 |
| 00816878020312 | K885029 | 000 |
| 00810182930701 | K885029 | 000 |