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 sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K142529
Device Name Genesis Reusable Rigid Container System
Applicant
CareFusion 2200 Inc
75 N Fairway Drive
Vernon Hills,  IL  60061
Applicant Contact Jane Weber
Correspondent
CareFusion 2200 Inc
75 N Fairway Drive
Vernon Hills,  IL  60061
Correspondent Contact Jane Weber
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/09/2014
Decision Date 01/08/2015
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
Recalls CDRH Recalls
-
-