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FDA 510(k) Application Details - K222422
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K222422
Device Name
Shunt, Central Nervous System And Components
Applicant
Sophysa
05 Rue Guy Moquet
Orsay 91400 FR
Other 510(k) Applications for this Company
Contact
Philippe Negre
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
08/11/2022
Decision Date
02/02/2023
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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