TOP WHOLESOME FACE MASK— 510(k) K984389

Substantially Equivalent

Top Wholesome Enterprise Co., Ltd.

FDA 510(k) clearance K984389 for TOP WHOLESOME FACE MASK, Substantially Equivalent on 1999-04-09. Applicant: Top Wholesome Enterprise Co., Ltd..

Clearance details

Applicant: Top Wholesome Enterprise Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1998-12-08
Decision date: 1999-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangna, TH

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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.