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FDA 510(k) Application Details - K963307
Device Classification Name
Device, Neurovascular Embolization
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510(K) Number
K963307
Device Name
Device, Neurovascular Embolization
Applicant
TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT, CA 94538 US
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Contact
LARAINE PANGELINA
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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
08/22/1996
Decision Date
12/17/1996
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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