Name: Predicase
Price: 199 USD

K-number	K143724
Device name	COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
Applicant	William A. Cook Australia Pty. , Ltd.
Product code	MQL
Device class	Class II
Decision date	Aug 27, 2015
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit

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