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 Pump, Infusion, Enteral
510(k) Number K141479
Device Name KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact TEGHPAL SINGH
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact TEGHPAL SINGH
Regulation Number880.5725
Classification Product Code
LZH  
Date Received06/04/2014
Decision Date 12/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-