K-number	K240925
Device name	DuraGraft Vascular Conduit Solution
Applicant	Marizyme
Product code	QEJ
Device class	Class II
Decision date	May 1, 2024
Decision	Substantially Equivalent
Regulation	876.4100

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Source

View the full FDA submission: accessdata.fda.gov

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DuraGraft Vascular Conduit Solution

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