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FDA 510(k) Application Details - K962990
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K962990
Device Name
Shunt, Central Nervous System And Components
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON, MA 01803-2516 US
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Contact
MICHAEL ARNOLD, PH.D.
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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
08/01/1996
Decision Date
10/23/1996
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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