FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS— 510(k) K050660

Substantially Equivalent

First Quality Hygienic, Inc.

FDA 510(k) clearance K050660 for FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS, Substantially Equivalent on 2005-05-12. Applicant: First Quality Hygienic, Inc..

Clearance details

Applicant: First Quality Hygienic, Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2005-03-15
Decision date: 2005-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, 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.