The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Navigus Trajectory Guide, Model Tg-xxxx.
| Device ID | K992304 |
| 510k Number | K992304 |
| Device Name: | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Contact | Michael J Renner |
| Correspondent | Michael J Renner IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-08 |
| Decision Date | 1999-08-27 |