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FDA 510(k) Application Details - K081465
Device Classification Name
Device, Vascular, For Promoting Embolization
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510(K) Number
K081465
Device Name
Device, Vascular, For Promoting Embolization
Applicant
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE, CA 92618 US
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Contact
NEELU MEDHEKAR
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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
05/27/2008
Decision Date
08/19/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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