K221810

Substantially Equivalent

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

Applicant: Bonraybio Co., Ltd.
Product code: MQK
Advisory panel: Obstetrics/Gynecology
Date received: 2022-06-22
Decision date: 2022-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

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