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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
510(k) Number K240925
Device Name DuraGraft Vascular Conduit Solution
Applicant
Marizyme
555 Heritage Dr.
Suite 205
Jupiter,  FL  33458
Applicant Contact Catherine Pachuk
Correspondent
Hogan Lovells US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John Smith
Classification Product Code
QEJ  
Date Received04/04/2024
Decision Date 05/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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