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

Name: FDA 510(k) clearance K221810
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

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.. Device class: 2.

Clearance details

Applicant: Bonraybio Co., Ltd.
Product code: Code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2022-06-22
Decision date: 2022-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

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