K122507 is an FDA 510(k) clearance for the DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION. 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 September 26, 2012, 40 days after receiving the submission on August 17, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K122507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2012 |
| Decision Date | September 26, 2012 |
| Days to Decision | 40 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 |