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— 510(k) K202607

Substantially Equivalent

String King Lacrosse, LLC

FDA 510(k) clearance K202607 for 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, Substantially Equivalent on 2021-04-23. Applicant: String King Lacrosse, LLC.

Clearance details

Applicant: String King Lacrosse, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-09-09
Decision date: 2021-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.