K-number	K170951
Device name	CardioCel 3D
Applicant	Admedus Regen Pty, Ltd.
Product code	PSQ
Device class	Class II
Decision date	Apr 28, 2017
Decision	Substantially Equivalent
Regulation	870.3470

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Source

View the full FDA submission: accessdata.fda.gov

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CardioCel 3D

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