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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 K192869
FOIA Releasable 510(k) K192869
Device Name SherpaPak Lung Preservation System , SherpaPak Liver Transport System
Applicant
Pragonix Technologies
Suite 408, 639 Granite St.
Braintree,  MA  02184
Applicant Contact Lisa Anderson
Correspondent
Northstar Biomedical Associates
93 Benefit St.
Providence,  RI  02904
Correspondent Contact Leo Basta
Regulation Number876.5880
Classification Product Code
KDN  
Date Received10/07/2019
Decision Date 01/16/2020
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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