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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K243384
Device Name Belzer UW® Cold Storage Solution (BTLBUW-001)
Applicant
Bridge TO Life
707 Skokie Blvd.,Suite 340
Northbrook,  IL  60062
Applicant Contact Mark Harper
Correspondent
Bridge TO Life
707 Skokie Blvd.,Suite 340
Northbrook,  IL  60062
Correspondent Contact Mark Harper
Regulation Number876.5880
Classification Product Code
KDN  
Subsequent Product Code
KDL  
Date Received10/31/2024
Decision Date 03/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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