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510(k) K191684

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System by Integra LifeSciences Corporation — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2019
Date Received
June 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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