MALE NATURAL RUBBER LATEX CONDOM— 510(k) K050244

Name: FDA 510(k) clearance K050244
Creator: U.S. Food and Drug Administration
Published: 2005-04-08

Substantially Equivalent

Nrs Global Partners

FDA 510(k) clearance K050244 for MALE NATURAL RUBBER LATEX CONDOM, Substantially Equivalent on 2005-04-08. Applicant: Nrs Global Partners. Device class: 2.

Clearance details

Applicant: Nrs Global Partners
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2005-02-02
Decision date: 2005-04-08
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.