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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K222297
Device Name CentriMag Pre-connected Pack
Applicant
Abbott
6035 Stoneridge Drive
Pleasanton,  CA  94588
Applicant Contact Kim Bondarenko
Correspondent
Abbott
6035 Stoneridge Drive
Pleasanton,  CA  94588
Correspondent Contact Kim Bondarenko
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTQ   DTR   DWA   DWF   KFM  
KRI  
Date Received08/01/2022
Decision Date 12/01/2022
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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