FDA 510(k) Application Details - K993417

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K993417
Device Name Device, Neurovascular Embolization
Applicant BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT, CA 94538 US
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Contact ROXANE BAXTER
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 10/01/1999
Decision Date 01/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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