ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON— 510(k) K983478

Substantially Equivalent

Organic Essentials

FDA 510(k) clearance K983478 for ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON, Substantially Equivalent on 1998-11-09. Applicant: Organic Essentials.

Clearance details

Applicant: Organic Essentials
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1998-10-02
Decision date: 1998-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: O'Donnell, TX, 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.