VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS— 510(k) K981953

Substantially Equivalent

Paragon Trade Brands, Inc.

FDA 510(k) clearance K981953 for VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS, Substantially Equivalent on 1998-08-18. Applicant: Paragon Trade Brands, Inc..

Clearance details

Applicant: Paragon Trade Brands, Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1998-06-03
Decision date: 1998-08-18
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.