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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K072697
Device Name 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
Applicant
3t Medical Systems, LLC
12553 S. Wamblee Valley Rd.
Conifer,  CO  80433
Applicant Contact ROBERT P EATON
Correspondent
3t Medical Systems, LLC
12553 S. Wamblee Valley Rd.
Conifer,  CO  80433
Correspondent Contact ROBERT P EATON
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Code
DTP  
Date Received09/24/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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