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 | K112535 |
| 510k Number | K112535 |
| Device Name: | GENESIS REUSABLE RIGID CONTAINER SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Kate Fuller |
| Correspondent | Kate Fuller CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-04-27 |
| Summary: | summary |