LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device— 510(k) K221810

Substantially Equivalent

Bonraybio Co., Ltd.

FDA 510(k) clearance K221810 for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device, Substantially Equivalent on 2022-10-31. Applicant: Bonraybio Co., Ltd..

Clearance details

Applicant: Bonraybio Co., Ltd.
Product code: 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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