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FDA 510(k) Application Details - K033704
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K033704
Device Name
Shunt, Central Nervous System And Components
Applicant
VYGON US LLC
2495 GENERAL ARMSTEAD AVE.
NORRISTOWN, PA 19403 US
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Contact
COURTNEY SMITH
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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
11/25/2003
Decision Date
05/27/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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