K112211 is an FDA 510(k) clearance for the DURA BLUE STERILIZATION WRAP. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on October 20, 2011, 79 days after receiving the submission on August 2, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K112211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2011 |
| Decision Date | October 20, 2011 |
| Days to Decision | 79 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 |