Submission Details
| 510(k) Number | K112211 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DURA BLUE STERILIZATION WRAP
Oct 2011
Decision
79d
Days
Class 2
Risk
About This 510(k) Submission
K112211 is an FDA 510(k) clearance for the DURA BLUE STERILIZATION WRAP, 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 review panel. Regulated under 21 CFR 880.6850.
Device Classification
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6850 |
Manufacturer
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