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

Device, Monitoring, Intracranial Pressure

Codman & Shurtleff, Inc

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc with the FDA for 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.

Pre-market Notification Details

Device IDK173192
510k NumberK173192
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
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Codman & Shurtleff, Inc 325 Paramount Drive Raynham,  MA  02767
ContactMegan Palumbo
CorrespondentMegan Palumbo
Codman & Shurtleff, Inc 325 Paramount Drive Raynham,  MA  02767
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-02
Decision Date2017-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780520696 K173192 000
10381780520689 K173192 000
10381780520672 K173192 000
10381780520702 K173192 000
10886704075462 K173192 000
10886704075455 K173192 000
10886704075448 K173192 000
10886704075431 K173192 000

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