KWIKEZE MALE CONDOM APPLICATOR— 510(k) K031007

Substantially Equivalent

Condax, LLC

FDA 510(k) clearance K031007 for KWIKEZE MALE CONDOM APPLICATOR, Substantially Equivalent on 2003-11-14. Applicant: Condax, LLC. Device class: 2.

Clearance details

Applicant: Condax, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2003-03-31
Decision date: 2003-11-14
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.