COTTONS 100% NATURAL COTTON TAMPONS— 510(k) K080733

Substantially Equivalent

Cottons Pty, Ltd.

FDA 510(k) clearance K080733 for COTTONS 100% NATURAL COTTON TAMPONS, Substantially Equivalent on 2009-02-18. Applicant: Cottons Pty, Ltd..

Clearance details

Applicant: Cottons Pty, Ltd.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2008-03-14
Decision date: 2009-02-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Denton, TX, US

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

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.