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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K081438
Device Name MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
Applicant
Lifenet Health
1864 Concert Dr.
Virginia Beach,  VA  23453
Applicant Contact ALYCE LINTHURST JONES
Correspondent
Lifenet Health
1864 Concert Dr.
Virginia Beach,  VA  23453
Correspondent Contact ALYCE LINTHURST JONES
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received05/22/2008
Decision Date 10/17/2008
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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