• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name orthopedic stereotaxic instrument
510(k) Number K121936
Device Name NAVIOPFS
Original Applicant
BLUE BELT TECHNOLOGIES, INC.
2828 liberty avenue
suite 100
pittsburgh,  PA  15222
Original Contact richard g confer
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/02/2012
Decision Date 11/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-