FDA 510(k) Application Details - DEN230002

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230002
Device Name	DuraGraft
Applicant	Marizyme, Inc. 555 Heritage Drive, Suite 205 Jupiter, FL 33458 US Other 510(k) Applications for this Company
Contact	Navdeep Kaur Cheema 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	01/03/2023
Decision Date	10/04/2023
Decision	DENG -
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review