The following data is part of a premarket notification filed by Medtronic Surgical Navigation with the FDA for Modification To Steathstation Treatment Guidance Platform.
| Device ID | K001153 |
| 510k Number | K001153 |
| Device Name: | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC SURGICAL NAVIGATION 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Victoria Rendon |
| Correspondent | Victoria Rendon MEDTRONIC SURGICAL NAVIGATION 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-05-03 |