ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P— 510(k) K123115

Substantially Equivalent

Acme Filter Mask, Inc.

FDA 510(k) clearance K123115 for ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P, Substantially Equivalent on 2013-05-20. Applicant: Acme Filter Mask, Inc..

Clearance details

Applicant: Acme Filter Mask, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2012-10-03
Decision date: 2013-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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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.