The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Universal Container System And Meditray Products.
| Device ID | K090068 |
| 510k Number | K090068 |
| Device Name: | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS |
| Classification | Wrap, Sterilization |
| Applicant | CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 -0402 |
| Contact | Tania Lupu |
| Correspondent | Tania Lupu CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 -0402 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-09 |
| Decision Date | 2010-02-24 |
| Summary: | summary |