Name: Predicase
Price: 199 USD

K-number	K221810
Device name	LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
Applicant	Bonraybio Co., Ltd.
Product code	MQK
Device class	Class II
Decision date	Oct 31, 2022
Decision	Substantially Equivalent
Regulation	884.6160

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

Everything you need for a 510(k) submission. Nothing you don't.