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FDA 510(k) Application Details - K120630
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K120630
Device Name
Device, Vascular, For Promoting Embolization
Applicant
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN, CA 92780 US
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Contact
CYNTHIA VALENZUELA
Other 510(k) Applications for this Contact
Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/01/2012
Decision Date
03/28/2012
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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