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FDA 510(k) Application Details - K162579
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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510(K) Number
K162579
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
Admedus Regen Pty Ltd
26 Harris Road
Malaga 6090 AU
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Contact
Mary E. Donlin
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Regulation Number
870.3470
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Classification Product Code
DXZ
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More FDA Info for this Product Code
Date Received
09/15/2016
Decision Date
10/14/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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