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FDA 510(k) Application Details - K113526
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K113526
Device Name
Shunt, Central Nervous System And Components
Applicant
MEDOS INTERNATIONAL SARL
325 Paramount Drive
Raynham, MA 02767 US
Other 510(k) Applications for this Company
Contact
JOCELYN RAPOSO
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
11/30/2011
Decision Date
02/16/2012
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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