'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9— 510(k) K001978

Name: FDA 510(k) clearance K001978
Creator: U.S. Food and Drug Administration
Published: 2000-08-08

Substantially Equivalent

Thai Nippon Rubber Industry Co., Ltd.

FDA 510(k) clearance K001978 for 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9, Substantially Equivalent on 2000-08-08. Applicant: Thai Nippon Rubber Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Thai Nippon Rubber Industry Co., Ltd.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 2000-06-29
Decision date: 2000-08-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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