RUBBER CONDOM (NON-COLORED)— 510(k) K896987

Name: FDA 510(k) clearance K896987
Creator: U.S. Food and Drug Administration
Published: 1990-06-06

Substantially Equivalent

Hankook Latex Gongup Co., Ltd.

FDA 510(k) clearance K896987 for RUBBER CONDOM (NON-COLORED), Substantially Equivalent on 1990-06-06. Applicant: Hankook Latex Gongup Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hankook Latex Gongup Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1989-12-13
Decision date: 1990-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, Korea, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.