K090068 is an FDA 510(k) clearance for the STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Case Medical, Inc. (Ridgefield, US). The FDA issued a Cleared decision on February 24, 2010, 411 days after receiving the submission on January 9, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K090068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2009 |
| Decision Date | February 24, 2010 |
| Days to Decision | 411 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |