TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS— 510(k) K062638

Substantially Equivalent

Procter & Gamble Co.

FDA 510(k) clearance K062638 for TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS, Substantially Equivalent on 2006-11-22. Applicant: Procter & Gamble Co..

Clearance details

Applicant: Procter & Gamble Co.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2006-09-05
Decision date: 2006-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
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.