Name: Predicase
Price: 199 USD

K-number	K092963
Device name	GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
Applicant	Genx Intl., Inc.
Product code	MQL
Device class	Class II
Decision date	Jan 14, 2011
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3

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