K-number	K162409
Device name	Gems Vitrification Set, Gems Warming Set
Applicant	Genea Biomedx Pty, Ltd.
Product code	MQL
Device class	Class II
Decision date	May 24, 2017
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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Gems Vitrification Set, Gems Warming Set

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