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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K232890
Device Name CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
Applicant
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Applicant Contact Kali Sacco
Correspondent
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Correspondent Contact Kali Sacco
Regulation Number882.1620
Classification Product Code
GWM  
Date Received09/18/2023
Decision Date 02/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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