The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Container System & Meditray Products.
| Device ID | K110682 |
| 510k Number | K110682 |
| Device Name: | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS |
| 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 | 2011-03-10 |
| Decision Date | 2011-07-01 |
| Summary: | summary |