The following data is part of a premarket notification filed by Denx Advanced Dental Systems with the FDA for Igi-system.
| Device ID | K023424 |
| 510k Number | K023424 |
| Device Name: | IGI-SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DENX ADVANCED DENTAL SYSTEMS MIZPE AVIV, INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Contact | Koby Ben-barak |
| Correspondent | Koby Ben-barak DENX ADVANCED DENTAL SYSTEMS MIZPE AVIV, INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-11 |
| Decision Date | 2003-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016855005 | K023424 | 000 |
| 07290016855012 | K023424 | 000 |