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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 K130872
Device Name CARDIOCEL
Applicant
Celxcel Pty, Ltd.
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Applicant Contact CHRISTOPHER SLOAN
Correspondent
Celxcel Pty, Ltd.
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact CHRISTOPHER SLOAN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received03/29/2013
Decision Date 01/30/2014
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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