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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 K173192
Device Name CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
Applicant
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact Megan Palumbo
Correspondent
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Megan Palumbo
Regulation Number882.1620
Classification Product Code
GWM  
Date Received10/02/2017
Decision Date 11/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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