The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Container System With Meditray Products.
| Device ID | K212711 |
| 510k Number | K212711 |
| Device Name: | SteriTite Container System With MediTray Products |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Case Medical, Inc. 50 West Street Bloomfield, NJ 07003 |
| Contact | Michael Polozani |
| Correspondent | Michael Polozani Case Medical, Inc. 50 West Street Bloomfield, NJ 07003 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-26 |
| Decision Date | 2022-04-29 |