LATEX PROPHYLACTIC (CONDOM)— 510(k) K912405

Name: FDA 510(k) clearance K912405
Creator: U.S. Food and Drug Administration
Published: 1992-07-21

Substantially Equivalent

Hevealactics Intl. Sdn Bhd

FDA 510(k) clearance K912405 for LATEX PROPHYLACTIC (CONDOM), Substantially Equivalent on 1992-07-21. Applicant: Hevealactics Intl. Sdn Bhd. Device class: 2.

Clearance details

Applicant: Hevealactics Intl. Sdn Bhd
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1991-05-30
Decision date: 1992-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Mirada, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.