Name: Predicase
Price: 199 USD

K-number	K152717
Device name	Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
Applicant	William A. Cook Australia Pty. , Ltd.
Product code	MQL
Device class	Class II
Decision date	May 6, 2016
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

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