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FDA 510(k) Application Details - K993415
Device Classification Name
Device, Neurovascular Embolization
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510(K) Number
K993415
Device Name
Device, Neurovascular Embolization
Applicant
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT, CA 94538 US
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Contact
ROXANE BAXTER
Other 510(k) Applications for this Contact
Regulation Number
882.5950
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Classification Product Code
HCG
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More FDA Info for this Product Code
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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