FEMTEX 100% COTTON TAMPONS— 510(k) K971228

Substantially Equivalent

Regu-Tech Assoc., Inc.

FDA 510(k) clearance K971228 for FEMTEX 100% COTTON TAMPONS, Substantially Equivalent on 1997-04-09. Applicant: Regu-Tech Assoc., Inc..

Clearance details

Applicant: Regu-Tech Assoc., Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1997-01-21
Decision date: 1997-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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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.