TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM— 510(k) K081413

Name: FDA 510(k) clearance K081413
Creator: U.S. Food and Drug Administration
Published: 2008-10-24

Substantially Equivalent

Dailian Latex Company, Ltd.

FDA 510(k) clearance K081413 for TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM, Substantially Equivalent on 2008-10-24. Applicant: Dailian Latex Company, Ltd.. Device class: 2.

Clearance details

Applicant: Dailian Latex Company, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2008-05-20
Decision date: 2008-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dailian City, Liaoning, 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.