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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
510(k) Number K232926
Device Name Novalung ultimate kit (US)
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Applicant Contact Amelia Huynh
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Correspondent Contact Amelia Huynh
Regulation Number870.4100
Classification Product Code
QJZ  
Subsequent Product Codes
BYS   QWF  
Date Received09/20/2023
Decision Date 04/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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