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FDA 510(k) Application Details - K060396
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device
510(K) Number
K060396
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact
JOSEPH P DE PAOLO
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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
02/15/2006
Decision Date
05/12/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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