The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Trajectory Guide, Model # Tgx-xxx.
| Device ID | K983539 |
| 510k Number | K983539 |
| Device Name: | TRAJECTORY GUIDE, MODEL # TGX-XXX |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 570 HALE AVENUE NORTH Oakdale, MN 55128 |
| Contact | Michael J Renner |
| Correspondent | Michael J Renner IMAGE-GUIDED NEUROLOGICS, INC. 570 HALE AVENUE NORTH Oakdale, MN 55128 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1999-02-12 |