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FDA 510(k) Application Details - K091952
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K091952
Device Name
Device, Vascular, For Promoting Embolization
Applicant
NFOCUS NEUROMEDICAL, INC.
2191 E. BAYSHORE ROAD
SUITE 100
PALO ALTO, CA 94303 US
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Contact
BOB O'HOLLA
Other 510(k) Applications for this Contact
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
07/01/2009
Decision Date
09/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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