FDA 510(k) Application Details - K240925

Device Classification Name	More FDA Info for this Device
510(K) Number	K240925
Device Name	DuraGraft Vascular Conduit Solution
Applicant	Marizyme 555 Heritage Drive Suite 205 Jupiter, FL 33458 US Other 510(k) Applications for this Company
Contact	Catherine Pachuk Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2024
Decision Date	05/01/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review