K130927 is an FDA 510(k) clearance for the DURABLUE 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 June 18, 2013, 76 days after receiving the submission on April 3, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K130927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2013 |
| Decision Date | June 18, 2013 |
| Days to Decision | 76 days |
| Submission Type | Special |
| 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 |