• 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 neurosurgical nerve locator
510(k) Number K120590
Device Name DILATOR TUBE SET
Original Applicant
KOROS USA, INC.
610 flinn ave.
moorpark,  CA  93021
Original Contact gabriel koros
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
GXZ  
Date Received02/28/2012
Decision Date 05/07/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-