The following data is part of a premarket notification filed by Neks Technologies with the FDA for Detectar, Model N123-mi.
| Device ID | K023367 |
| 510k Number | K023367 |
| Device Name: | DETECTAR, MODEL N123-MI |
| Classification | Handle, Instrument, Dental |
| Applicant | NEKS TECHNOLOGIES 103 NOLEN LN. Chapel Hill, NC 27516 |
| Contact | Charles H Kyper |
| Correspondent | Charles H Kyper NEKS TECHNOLOGIES 103 NOLEN LN. Chapel Hill, NC 27516 |
| Product Code | EJB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2003-06-25 |
| Summary: | summary |