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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K031151
Device Name TS3 TUBING SET
Applicant
GLOBAL BLOOD RESOURCES, LLC
998 WINDSOR AVE.
WINDSOR,  CT  06095
Applicant Contact KEITH SAMOLYK
Correspondent
GLOBAL BLOOD RESOURCES, LLC
998 WINDSOR AVE.
WINDSOR,  CT  06095
Correspondent Contact KEITH SAMOLYK
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/10/2003
Decision Date 06/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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