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FDA 510(k) Application Details - K071699
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K071699
Device Name
Device, Vascular, For Promoting Embolization
Applicant
AGA MEDICAL CORP.
5050 NATHAN LANE NORTH
PLYMOUTH, MN 55442 US
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Contact
JODI L RAUS
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Regulation Number
870.3300
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Classification Product Code
KRD
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More FDA Info for this Product Code
Date Received
06/21/2007
Decision Date
08/15/2007
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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