K092437 is an FDA 510(k) clearance for the CODMAN STERILIZATION CONTAINERS. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on March 25, 2010, 230 days after receiving the submission on August 7, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K092437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2009 |
| Decision Date | March 25, 2010 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |