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FDA 510(k) Application Details - K040201
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K040201
Device Name
Shunt, Central Nervous System And Components
Applicant
INTEGRA NEUROSCIENCES IMPLANTS S.A.
311 ENTERPRISE DRIVE
PLAINSBORO, NJ 08536 US
Other 510(k) Applications for this Company
Contact
JUDITH E O'GRADY
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
01/29/2004
Decision Date
02/26/2004
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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