F10— 510(k) K110630

Substantially Equivalent

Mediana Co., Ltd.

FDA 510(k) clearance K110630 for F10, Substantially Equivalent on 2011-06-24. Applicant: Mediana Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mediana Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2011-03-03
Decision date: 2011-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-City, Gangwon-Do, 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.