Submission Details
| 510(k) Number | K112918 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2011 |
| Decision Date | January 20, 2012 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
Jan 2012
Decision
109d
Days
Class 2
Risk
About This 510(k) Submission
K112918 is an FDA 510(k) clearance for the DURABLUE STERILIZATION (AMSCO V-PRO) 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 January 20, 2012, 109 days after receiving the submission on October 3, 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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