ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM— 510(k) K082529

Name: FDA 510(k) clearance K082529
Creator: U.S. Food and Drug Administration
Published: 2009-05-01

Substantially Equivalent

Alatech Healthcare, LLC

FDA 510(k) clearance K082529 for ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM, Substantially Equivalent on 2009-05-01. Applicant: Alatech Healthcare, LLC. Device class: 2.

Clearance details

Applicant: Alatech Healthcare, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2008-09-02
Decision date: 2009-05-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Eufaula, AL, 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.