TERRA FEMME— 510(k) K930400

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..

Clearance details

Applicant: Bio Business Intl, Inc.
Product code: Code HEB
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 ↗

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.