• 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 K121085
Device Name HET BIPOLAR LIGATOR SYSTEM
Original Applicant
HET SYSTEMS, LLC
1152 navarro st, ste 2001
santa rosa,  CA  95401
Original Contact shelley trimm
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/11/2012
Decision Date 11/20/2012
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
-
-