Name: Predicase
Price: 199 USD

K-number	K200408
Device name	VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Applicant	Shenzhen Vitavitro Biotech Co., Ltd.
Product code	MQL
Device class	Class II
Decision date	Oct 16, 2020
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

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