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FDA 510(k) Application Details - K965071
Device Classification Name
Balloon,Detachable,For Neurovascular Occlusion
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510(K) Number
K965071
Device Name
Balloon,Detachable,For Neurovascular Occlusion
Applicant
TARGET THERAPEUTICS
47201 LAKEVIEW DR.
FREEMONT, CA 94538-6530 US
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Contact
LYNN K BELL
Other 510(k) Applications for this Contact
Regulation Number
882.5950
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Classification Product Code
MZQ
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More FDA Info for this Product Code
Date Received
12/19/1996
Decision Date
04/21/1998
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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