The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Stealthstation.
| Device ID | K954276 |
| 510k Number | K954276 |
| Device Name: | STEALTHSTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Contact | Kurt R Smith |
| Correspondent | Kurt R Smith SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield, CO 80020 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-13 |
| Decision Date | 1996-01-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STEALTHSTATION 75025042 2191709 Live/Registered |
MEDTRONIC NAVIGATION, INC. 1995-11-28 |