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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 K143054
Device Name Sherpa Pak Kidney Transport System
Applicant
Paragonix Technologies, Inc.
639 Granite St.
Braintree,  MA  02184
Applicant Contact Lisa Anderson
Correspondent
Texel Fortis, LLC
150 Levinberg Ln.
Wayne,  NJ  07470
Correspondent Contact Mason Diamond
Regulation Number876.5880
Classification Product Code
KDN  
Subsequent Product Code
PIN  
Date Received10/23/2014
Decision Date 11/25/2014
Decision Substantially Equivalent - Kit (SESK)
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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