The following data is part of a premarket notification filed by Carefusion 2200 Inc with the FDA for Genesis Reusable Rigid Container System.
Device ID | K142529 |
510k Number | K142529 |
Device Name: | Genesis Reusable Rigid Container System |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | CareFusion 2200 Inc 75 N Fairway Drive Vernon Hills, IL 60061 |
Contact | Jane Weber |
Correspondent | Jane Weber CareFusion 2200 Inc 75 N Fairway Drive Vernon Hills, IL 60061 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-09 |
Decision Date | 2015-01-08 |
Summary: | summary |