K173225

Substantially Equivalent

Interlude and private label Unscented 3-piece compact applicator tampon

Applicant: Albaad Fem
Product code: HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2017-10-03
Decision date: 2018-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea Ind. Park, IL

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.