• 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 syringe, antistick
510(k) Number K121637
Model 5ML
Device Name AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
Original Applicant
SUNWELL BIOTECH CO., LTD
77325 joyce way
echo,  OR  97826
Original Contact charlie mack
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/04/2012
Decision Date 10/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-