THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM— 510(k) K032909

Name: FDA 510(k) clearance K032909
Creator: U.S. Food and Drug Administration
Published: 2003-12-16

Substantially Equivalent

Thai Nippon Rubber Industry Co., Ltd.

FDA 510(k) clearance K032909 for THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM, Substantially Equivalent on 2003-12-16. Applicant: Thai Nippon Rubber Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Thai Nippon Rubber Industry Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2003-09-17
Decision date: 2003-12-16
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.