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 Cap, Device Disinfectant
510(k) Number K113842
Device Name CATHETER CONNECTIONS' DUALCAP SOLO
Applicant
CATHETER CONNECTIONS, INC.
2455 E Parleys Way - Suite 150
Salt Lake City,  UT  84109
Applicant Contact DONALD D SOLOMON
Correspondent
CATHETER CONNECTIONS, INC.
2455 E Parleys Way - Suite 150
Salt Lake City,  UT  84109
Correspondent Contact DONALD D SOLOMON
Regulation Number880.5440
Classification Product Code
QBP  
Date Received12/28/2011
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-