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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 K200566
Device Name ADAPT Tissue
Applicant
Admedus Regen Pty, Ltd.
26 Harris Rd.
Malaga,  AU 6080
Applicant Contact Kiran Bhirangi
Correspondent
Admedus Regen Pty, Ltd.
860 Blue Gentian Rd.
Suite 340
Eagan,  MN  55121
Correspondent Contact Diana Upp
Regulation Number870.3470
Classification Product Code
PSQ  
Date Received03/04/2020
Decision Date 04/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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