TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED— 510(k) K113699

Substantially Equivalent

The Procter & Gamble Company

FDA 510(k) clearance K113699 for TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED, Substantially Equivalent on 2012-01-12. Applicant: The Procter & Gamble Company.

Clearance details

Applicant: The Procter & Gamble Company
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2011-12-16
Decision date: 2012-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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.