• 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 electrosurgical, cutting & coagulation & accessories
510(k) Number K113090
Model M001262260,M001262270,M001262280,M001262290
Device Name LEVEEN SUPERSLIM NEEDLE ELECTRODE
Original Applicant
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough,  MA  01752
Original Contact ashley pyle
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/19/2011
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-