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FDA 510(k) Application Details - K110584
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
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510(K) Number
K110584
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
ASAHI INTECC CO., LTD.
2500 RED HILL SUITE 210
SANTA ANA, CA 92705 US
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Contact
YOSHI TERAI
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Regulation Number
870.1330
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Classification Product Code
MOF
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More FDA Info for this Product Code
Date Received
03/01/2011
Decision Date
08/22/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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