K210705 is an FDA 510(k) clearance for the Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Defender Safety, Inc. (Plainview, US). The FDA issued a Cleared decision on May 6, 2021, 58 days after receiving the submission on March 9, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2021 |
| Decision Date | May 06, 2021 |
| Days to Decision | 58 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |