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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K181902
Device Name Codman Certas Plus Electronic Tool Kit
Applicant
Integra Lifesciences Corp.
11 Cabot Blvd.
Mansfield,  MA  02048
Applicant Contact Nancy MacDonald
Correspondent
Integra Lifesciences Corp.
11 Cabot Blvd.
Mansfield,  MA  02048
Correspondent Contact Nancy MacDonald
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/16/2018
Decision Date 10/25/2018
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
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