Submission Details
| 510(k) Number | K142990 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 2014 |
| Decision Date | March 04, 2015 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Insta-Gard Surgical and Procedure Face Mask
Mar 2015
Decision
139d
Days
Class 2
Risk
About This 510(k) Submission
K142990 is an FDA 510(k) clearance for the Insta-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 March 4, 2015, 139 days after receiving the submission on October 16, 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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