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 |