• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name plate, bone
510(k) Number K091679
Device Name LEFORTE SYSTEM BONE PLATE
Original Applicant
JEIL MEDICAL CORPORATION
215 s. state street
ste: 100b
salt lake city,  UT  84111
Original Contact shin kuk yoo
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/09/2009
Decision Date 10/02/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-