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FDA 510(k) Application Details - K093002
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K093002
Device Name
Device, Vascular, For Promoting Embolization
Applicant
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN, CA 92780 US
Other 510(k) Applications for this Company
Contact
Naomi Gong
Other 510(k) Applications for this Contact
Regulation Number
870.3300
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Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2009
Decision Date
10/28/2009
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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