TERRA FEMME— 510(k) K930400

Name: FDA 510(k) clearance K930400
Creator: U.S. Food and Drug Administration
Published: 1994-03-14

Substantially Equivalent

Bio Business Intl, Inc.

FDA 510(k) clearance K930400 for TERRA FEMME, Substantially Equivalent on 1994-03-14. Applicant: Bio Business Intl, Inc.. Device class: 2.

Clearance details

Applicant: Bio Business Intl, Inc.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1993-01-26
Decision date: 1994-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada M6g 3x3, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEB

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K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS2025-10-09
K252613 — Unscented menstrual three-piece applicator tampon2025-09-19
K251033 — Unscented menstrual long applicator tampon +3 more2025-08-13

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.