QUALIS— 510(k) K133295

Substantially Equivalent

Menicon Co., Ltd. New Business Division

FDA 510(k) clearance K133295 for QUALIS, Substantially Equivalent on 2014-06-18. Applicant: Menicon Co., Ltd. New Business Division. Device class: 2.

Clearance details

Applicant: Menicon Co., Ltd. New Business Division
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2013-10-25
Decision date: 2014-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.