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FDA 510(k) Application Details - K081942
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K081942
Device Name
Shunt, Central Nervous System And Components
Applicant
VYGON NEURO
2495 GENERAL ARMISTEAD 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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Date Received
07/08/2008
Decision Date
08/12/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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