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510(k) K183406

CereLink ICP Monitor, CereLink ICP Extension Cable by Integra Lifesciences Corp. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
December 10, 2018
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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