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FDA 510(k) Application Details - K080168
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K080168
Device Name
Shunt, Central Nervous System And Components
Applicant
NEURO DIAGNOSTIC DEVICES
ONE NESHAMAMINY INTERPLEX
SUITE 300
TREVOSE, PA 19053 US
Other 510(k) Applications for this Company
Contact
FREDERICK J FRITZ
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/23/2008
Decision Date
05/16/2008
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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