Submission Details
| 510(k) Number | K151445 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 2015 |
| Decision Date | December 21, 2015 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health Sterilization Wrap
Dec 2015
Decision
206d
Days
Class 2
Risk
About This 510(k) Submission
K151445 is an FDA 510(k) clearance for the Cardinal Health 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 December 21, 2015, 206 days after receiving the submission on May 29, 2015. 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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