FDA 510(k) Application Details - K050700

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K050700
Device Name Device, Neurovascular Embolization
Applicant BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT, CA 94538-6515 US
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Contact JAMES LEATHLEY
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 03/18/2005
Decision Date 04/15/2005
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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