The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Neuro-trace Iii Kit, Neuro-trace Iii Regional Block Cable, Neuro-trace Iii Nerve Mapping Probe, Neuro-trace Iii Nerve Bg.
| Device ID | K023342 |
| 510k Number | K023342 |
| Device Name: | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | HDC CORP. 628 GIBRALTAR COURT Milpitas, CA 95035 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 628 GIBRALTAR COURT Milpitas, CA 95035 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2004-03-02 |
| Summary: | summary |