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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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, administration, intravascular
510(k) Number K130416
Device Name NEXUS TKO-6P LUER ACTIVATED DEVICE
Applicant
NEXUS MEDICAL, LLC
11315 STRANG LINE ROAD
LENEXA,  KS  66215
Applicant Contact HEATHER TURNER
Correspondent
NEXUS MEDICAL, LLC
11315 STRANG LINE ROAD
LENEXA,  KS  66215
Correspondent Contact HEATHER TURNER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/19/2013
Decision Date 06/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-