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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intracardiac patch or pledget, biologically derived
510(k) Number K191734
Device Name MatriStem UBM Pericardial Patch
Applicant
Acell, Inc.
6640 Eli Whitney Drive
Suite 200
Columbia,  MD  21046
Applicant Contact Michelle Huettner
Correspondent
Acell, Inc.
6640 Eli Whitney Drive
Suite 200
Columbia,  MD  21046
Correspondent Contact Michelle Huettner
Regulation Number870.3470
Classification Product Code
PSQ  
Date Received06/28/2019
Decision Date 11/22/2019
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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