The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Foldalite Unit.
| Device ID | K827890 |
| 510k Number | K827890 |
| Device Name: | FOLDALITE UNIT |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | 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 | 1982-08-11 |
| Decision Date | 1982-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816878020862 | K827890 | 000 |
| 00816878020060 | K827890 | 000 |
| 00816878020077 | K827890 | 000 |
| 00816878020084 | K827890 | 000 |
| 00816878020091 | K827890 | 000 |
| 00816878020107 | K827890 | 000 |
| 00816878020305 | K827890 | 000 |
| 00816878020336 | K827890 | 000 |
| 00816878020619 | K827890 | 000 |
| 00816878020824 | K827890 | 000 |
| 00816878020855 | K827890 | 000 |
| 00816878020046 | K827890 | 000 |