The following data is part of a premarket notification filed by Neogenex with the FDA for Human Newborn Foreskin Cell Culture.
| Device ID | K943887 |
| 510k Number | K943887 |
| Device Name: | HUMAN NEWBORN FORESKIN CELL CULTURE |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Contact | William E Radany |
| Correspondent | William E Radany NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-09 |
| Decision Date | 1994-11-28 |