Banana Gold— 510(k) K150857

Substantially Equivalent

Hankook Latex Gongup Co., Ltd.

FDA 510(k) clearance K150857 for Banana Gold, Substantially Equivalent on 2015-08-14. 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: 2015-03-31
Decision date: 2015-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuncheon-Si, 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.