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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 K191407
Device Name Novalung System
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Applicant Contact Denise Oppermann
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Correspondent Contact Denise Oppermann
Regulation Number870.4100
Classification Product Code
QJZ  
Date Received05/28/2019
Decision Date 02/21/2020
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
Recalls CDRH Recalls
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