LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT— 510(k) K010371

Name: FDA 510(k) clearance K010371
Creator: U.S. Food and Drug Administration
Published: 2001-04-27

Substantially Equivalent

Suretex, Ltd.

FDA 510(k) clearance K010371 for LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT, Substantially Equivalent on 2001-04-27. Applicant: Suretex, Ltd.. Device class: 2.

Clearance details

Applicant: Suretex, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2001-02-07
Decision date: 2001-04-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dothan, AL, US

Download summary PDF View on FDA.gov ↗

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K030176 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT2003-04-17
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Data sourced from openFDA. This site is unofficial and independent of the FDA.