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FDA 510(k) Application Details - K041716
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device
510(K) Number
K041716
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
BOSTON SCIENTIFIC CORP.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact
MAUREEN MONTBRIAND
Other 510(k) Applications for this Contact
Regulation Number
870.3470
More FDA Info for this Regulation Number
Classification Product Code
DXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2004
Decision Date
07/22/2004
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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