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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 K203262
Device Name Cannula for Organ Perfusion
Applicant
Bridge To Life, Ltd.
128 Suber Rd. Suite A
Columbia,  SC  29210
Applicant Contact Brett Schultz
Correspondent
Wood Burditt Group
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact H Carl Jenkins
Regulation Number876.5880
Classification Product Code
KDN  
Subsequent Product Code
MSB  
Date Received11/05/2020
Decision Date 07/01/2021
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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