K992493

Substantially Equivalent

VIPON TAMPON

Applicant
Another Way Products, LLC
Product code
HEB
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raymore, MO, 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, 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.