K023614 is an FDA 510(k) clearance for the STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM. 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 April 7, 2003, 161 days after receiving the submission on October 28, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K023614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2002 |
| Decision Date | April 07, 2003 |
| Days to Decision | 161 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 |