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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System And Accessories, Isolated Heart, Transport And Preservation
510(k) Number K180194
Device Name SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Applicant
Paragonix Technologies, Inc.
D/O Vaughn & Asociates
639 Granite St.
Braintree,  MA  02118
Applicant Contact Leo Basta
Correspondent
Northstar Biomedical Associates
93 Benefit St.
Providence,  RI  02904
Correspondent Contact Leo Basta
Regulation Number876.5880
Classification Product Code
MSB  
Subsequent Product Code
KDN  
Date Received01/24/2018
Decision Date 03/30/2018
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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