FDA 510(k) Application Details - K140104

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K140104
Device Name Device, Neurovascular Embolization
Applicant BLOCKADE MEDICAL
18 Technology Dr Ste 169
Irvine, CA 92618 US
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Contact Rebecca K Pine
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 01/15/2014
Decision Date 02/13/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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