Submission Details
| 510(k) Number | K180874 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 03, 2018 |
| Decision Date | July 31, 2018 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
Jul 2018
Decision
119d
Days
Class 2
Risk
About This 510(k) Submission
K180874 is an FDA 510(k) clearance for the 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on July 31, 2018, 119 days after receiving the submission on April 3, 2018. 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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