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510(k) K130872

CARDIOCEL by Celxcel Pty, Ltd. — Product Code DXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2014
Date Received
March 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

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