Submission Details
| 510(k) Number | K192374 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2019 |
| Decision Date | December 02, 2019 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health? Level 3 Surgical Mask with Anti-Fog Foam Strip
Dec 2019
Decision
94d
Days
Class 2
Risk
About This 510(k) Submission
K192374 is an FDA 510(k) clearance for the Cardinal Health? Level 3 Surgical Mask with Anti-Fog Foam Strip, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on December 2, 2019, 94 days after receiving the submission on August 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
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