QUALIS— 510(k) K133295
Substantially EquivalentMenicon 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
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.