• 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 negative pressure wound therapy powered suction pump
510(k) Number K122490
Model PUSF, PUMP, PULF
Device Name KULAVAC
Original Applicant
CGBIO CO., LTD
163-3 samsung-dong
kangnam-gu
seoul,  KS 135-715
Original Contact jungeun im
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/15/2012
Decision Date 11/13/2013
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
-
-