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FDA 510(k) Application Details - K974708
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K974708
Device Name
Shunt, Central Nervous System And Components
Applicant
NEUROCARE GROUP
8401 102ND STREET, SUITE 200
P.O. BOX 390
PLEASANT PRAIRIE, WI 53158-0390 US
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LORI L HAYS
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Regulation Number
882.5550
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Classification Product Code
JXG
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More FDA Info for this Product Code
Date Received
12/17/1997
Decision Date
03/10/1998
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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