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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 K133694
Device Name SHERPA PAK TRANSPORTER
Applicant
Paragonix Technologies, Inc.
93 Benefit St.
Providence,  RI  02904
Applicant Contact LEO BASTA
Correspondent
Paragonix Technologies, Inc.
93 Benefit St.
Providence,  RI  02904
Correspondent Contact LEO BASTA
Regulation Number876.5880
Classification Product Code
KDN  
Date Received12/03/2013
Decision Date 05/23/2014
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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