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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 K131184
Device Name INTEGRA LICOX PTO2 MONITOR
Applicant
INTEGRA LIFESCIENCES CORP.
22 TERRY AVENUE
BURLINGTON,  MA  01830
Applicant Contact ELIZABETH MCMENIMAN
Correspondent
INTEGRA LIFESCIENCES CORP.
22 TERRY AVENUE
BURLINGTON,  MA  01830
Correspondent Contact ELIZABETH MCMENIMAN
Regulation Number882.1620
Classification Product Code
GWM  
Date Received04/25/2013
Decision Date 08/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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