TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)— 510(k) K061486

Substantially Equivalent

Procter & Gamble Co.

FDA 510(k) clearance K061486 for TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES), Substantially Equivalent on 2006-08-01. Applicant: Procter & Gamble Co..

Clearance details

Applicant
Procter & Gamble Co.
Product code
Code HEB
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HEB

product code HEB
Injury
329
Malfunction
5,647
Total
5,976

Source: openFDA MAUDE database, through . 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.