Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K990214
Device Name FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
Applicant
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Applicant Contact ROGER N WHITE
Correspondent
SURGICAL NAVIGATION TECHNOLOGIES, INC.
530 COMPTON ST.
BROOMFIELD,  CO  80020
Correspondent Contact ROGER N WHITE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/22/1999
Decision Date 04/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-