Submission Details
| 510(k) Number | K130927 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
DURABLUE STERILIZATION WRAP
Jun 2013
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K130927 is an FDA 510(k) clearance for the DURABLUE 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 June 18, 2013, 76 days after receiving the submission on April 3, 2013. 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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