UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)— 510(k) K023175

Name: FDA 510(k) clearance K023175
Creator: U.S. Food and Drug Administration
Published: 2002-12-13

Substantially Equivalent

Unidus Corp.

FDA 510(k) clearance K023175 for UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING), Substantially Equivalent on 2002-12-13. Applicant: Unidus Corp.. Device class: 2.

Clearance details

Applicant: Unidus Corp.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2002-09-23
Decision date: 2002-12-13
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.