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FDA 510(k) Application Details - K973525
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K973525
Device Name
Shunt, Central Nervous System And Components
Applicant
INTEGRA NEUROCARE LLC.
8401 102ND ST.
SUITE 200-P.O. BOX 390
PLEASANT PRAIRIE, WI 53150-0390 US
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Contact
LORI L HAYS, MT (ASCP)
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
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More FDA Info for this Product Code
Date Received
09/17/1997
Decision Date
12/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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