DUREX FLAVORED LATEX CONDOM— 510(k) K032227

Substantially Equivalent

Ssl Americas, Inc.

FDA 510(k) clearance K032227 for DUREX FLAVORED LATEX CONDOM, Substantially Equivalent on 2004-03-29. Applicant: Ssl Americas, Inc.. Device class: 2.

Clearance details

Applicant: Ssl Americas, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2003-07-21
Decision date: 2004-03-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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K042958 — DUREX PLAY TINGLING LUBRICANT2005-04-08
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Data sourced from openFDA. This site is unofficial and independent of the FDA.