Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name set, i.v. fluid transfer
510(K) Number K121182
Device Name VIALOK NON-VENTED
Applicant
YUKON MEDICAL, LLC
4819-400 emperor blvd
durham,  NC  27703
Contact carl dupper
Regulation Number880.5440
Classification Product Code
LHI  
Date Received04/18/2012
Decision Date 05/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-