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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 K183406
Device Name CereLink ICP Monitor, CereLink ICP Extension Cable
Applicant
Integra LifeSciences Corp.
11 Cabot Blvd
Mansfield,  MA  02048
Applicant Contact Megan Palumbo
Correspondent
Integra LifeSciences Corp.
11 Cabot Blvd
Mansfield,  MA  02048
Correspondent Contact Megan Palumbo
Regulation Number882.1620
Classification Product Code
GWM  
Date Received12/10/2018
Decision Date 01/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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