K202607 is an FDA 510(k) clearance for the Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by String King Lacrosse, LLC (Gardena, US). The FDA issued a Cleared decision on April 23, 2021, 226 days after receiving the submission on September 9, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2020 |
| Decision Date | April 23, 2021 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |