Submission Details
| 510(k) Number | K181174 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2018 |
| Decision Date | December 11, 2018 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health Sterilization Wrap
Dec 2018
Decision
223d
Days
Class 2
Risk
About This 510(k) Submission
K181174 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 11, 2018, 223 days after receiving the submission on May 2, 2018. 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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