SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON— 510(k) K861911

Substantially Equivalent

Tambrands, Inc.

FDA 510(k) clearance K861911 for SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON, Substantially Equivalent on 1986-08-12. Applicant: Tambrands, Inc..

Clearance details

Applicant: Tambrands, Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1986-05-19
Decision date: 1986-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palmer, MA, 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.