Submission Details
| 510(k) Number | K120658 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 2012 |
| Decision Date | June 13, 2012 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
DURABLUE STERILIZATION WRAP
Jun 2012
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K120658 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 13, 2012, 100 days after receiving the submission on March 5, 2012. 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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