MERCATOR HEALTHCARE MALE LATEX CONDOM— 510(k) K031369

Name: FDA 510(k) clearance K031369
Creator: U.S. Food and Drug Administration
Published: 2003-10-31

Substantially Equivalent

Mercator Healthcare , Ltd.

FDA 510(k) clearance K031369 for MERCATOR HEALTHCARE MALE LATEX CONDOM, Substantially Equivalent on 2003-10-31. Applicant: Mercator Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Mercator Healthcare , Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2003-04-30
Decision date: 2003-10-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Durham, NC, 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.