aoni Natural Rubber Latex Condom— 510(k) K153016

Name: FDA 510(k) clearance K153016
Creator: U.S. Food and Drug Administration
Published: 2016-10-20

Substantially Equivalent

Guangzhou Daming United Rubber Products , Ltd.

FDA 510(k) clearance K153016 for aoni Natural Rubber Latex Condom, Substantially Equivalent on 2016-10-20. Applicant: Guangzhou Daming United Rubber Products , Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Daming United Rubber Products , Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2015-10-15
Decision date: 2016-10-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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