The following data is part of a premarket notification filed by Carefusion 2200 Inc with the FDA for Genesis Low Temperature Reusable Rigid Container System.
| Device ID | K153554 |
| 510k Number | K153554 |
| Device Name: | Genesis Low Temperature 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 | 2015-12-14 |
| Decision Date | 2016-03-21 |
| Summary: | summary |