AMSEAL SURGICAL FACE MASK— 510(k) K964358

Substantially Equivalent

American Seal Co.

FDA 510(k) clearance K964358 for AMSEAL SURGICAL FACE MASK, Substantially Equivalent on 1997-02-14. Applicant: American Seal Co..

Clearance details

Applicant: American Seal Co.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1996-11-01
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, 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.