Submission Details
| 510(k) Number | K140155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 2014 |
| Decision Date | June 20, 2014 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
Jun 2014
Decision
149d
Days
Class 2
Risk
About This 510(k) Submission
K140155 is an FDA 510(k) clearance for the SECURE-GARD SURGICAL AND PROCEDURE FACE MASK, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 20, 2014, 149 days after receiving the submission on January 22, 2014. 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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