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510(k) K210993

CereLink ICP Monitor by Integra Lifesciences Production Corporation — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2021
Date Received
April 2, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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