Submission Details
| 510(k) Number | K151788 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2015 |
| Decision Date | October 30, 2015 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health Sterilization Wrap
Oct 2015
Decision
121d
Days
Class 2
Risk
About This 510(k) Submission
K151788 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 October 30, 2015, 121 days after receiving the submission on July 1, 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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