Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3— 510(k) K211066

Substantially Equivalent

Homtex, Inc.

FDA 510(k) clearance K211066 for Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3, Substantially Equivalent on 2021-08-19. Applicant: Homtex, Inc..

Clearance details

Applicant: Homtex, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-04-12
Decision date: 2021-08-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cullman, AL, 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.