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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 K123326
Device Name SHERPA PAK CARDIAC TRANSPORT SYSTEM
Applicant
Paragonix Technologies, Inc.
755 Westminister St. Unit 120
Providence,  MA  02903
Applicant Contact LEO BASTA
Correspondent
Paragonix Technologies, Inc.
755 Westminister St. Unit 120
Providence,  MA  02903
Correspondent Contact LEO BASTA
Regulation Number876.5880
Classification Product Code
MSB  
Date Received10/26/2012
Decision Date 02/06/2013
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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