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FDA 510(k) Application Details - K170951
Device Classification Name
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510(K) Number
K170951
Device Name
CardioCel 3D
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
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Classification Product Code
PSQ
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Date Received
03/31/2017
Decision Date
04/28/2017
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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