FDA 510(k) Application Details - K022427

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K022427
Device Name Device, Neurovascular Embolization
Applicant BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK
GLENS FALLS, NY 12801-3864 US
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Contact JODI LYNN GREENIZEN
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 07/25/2002
Decision Date 08/22/2002
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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