TAMPON, UNTREATED— 510(k) K950194

Name: FDA 510(k) clearance K950194
Creator: U.S. Food and Drug Administration
Published: 1995-08-25

Substantially Equivalent

Hygieia Healthcare , Ltd.

FDA 510(k) clearance K950194 for TAMPON, UNTREATED, Substantially Equivalent on 1995-08-25. Applicant: Hygieia Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Hygieia Healthcare , Ltd.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1995-01-18
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castletown, Sunderland Sr5 3rx, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Hygieia Healthcare , Ltd.

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K954445 — NON APPLICATOR TAMPON, UNTREATED1996-02-12
K912941 — TAMPON, UNTREATED1992-03-06

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.