O.B. APPLICATOR TAMPONS, O.B. TAMPONS— 510(k) K991118

Substantially Equivalent

Personal Products Co.

FDA 510(k) clearance K991118 for O.B. APPLICATOR TAMPONS, O.B. TAMPONS, Substantially Equivalent on 1999-06-29. Applicant: Personal Products Co..

Clearance details

Applicant: Personal Products Co.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1999-04-01
Decision date: 1999-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, 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.