K-number	K182010
Device name	ProgenaMatrix
Applicant	Cell Constructs I, LLC
Product code	KGN
Device class	Class U
Decision date	Jan 17, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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ProgenaMatrix

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