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FDA 510(k) Application Details - K222471
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K222471
Device Name
Shunt, Central Nervous System And Components
Applicant
IRRAS USA
11975 El Camino Real, Suite 304
San Diego, CA 92130 US
Other 510(k) Applications for this Company
Contact
Jeanne S Warner
Other 510(k) Applications for this Contact
Regulation Number
882.5550
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Classification Product Code
JXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2022
Decision Date
12/08/2022
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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