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FDA 510(k) Application Details - K122306
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device
510(K) Number
K122306
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
SYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE.
WEST
ST. PAUL, MN 55114-1024 US
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Contact
JODI JORGENSON
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Regulation Number
870.3470
More FDA Info for this Regulation Number
Classification Product Code
DXZ
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More FDA Info for this Product Code
Date Received
08/01/2012
Decision Date
03/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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