The following data is part of a premarket notification filed by Case Medical, Inc with the FDA for Case Medical Steritite Reusable Rigid Sterilization Container System With Meditray Accessories.
| Device ID | K173259 |
| 510k Number | K173259 |
| Device Name: | Case Medical SteriTite Reusable Rigid Sterilization Container System With MediTray Accessories |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Case Medical, Inc 19 Empire Blvd South Hackensack, NJ 07606 |
| Contact | Tania Lupu |
| Correspondent | Tania Lupu Case Medical, Inc 19 Empire Blvd South Hackensack, NJ 07606 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-10 |
| Decision Date | 2018-06-13 |
| Summary: | summary |