O.B. TAMPON— 510(k) K941863

Substantially Equivalent

Personal Products Co.

FDA 510(k) clearance K941863 for O.B. TAMPON, Substantially Equivalent on 1994-06-27. Applicant: Personal Products Co..

Clearance details

Applicant: Personal Products Co.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1994-04-15
Decision date: 1994-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milltown, 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.