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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 K121573
Device Name INTEGRA CAMINO ICP MONITOR
Applicant
Intrgra Lifesciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact Erin Doyle
Correspondent
Intrgra Lifesciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact Erin Doyle
Regulation Number882.1620
Classification Product Code
GWM  
Date Received05/29/2012
Decision Date 09/10/2012
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
Recalls CDRH Recalls
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