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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 K062599
Device Name MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08540
Applicant Contact DARLENE M WELSH
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08540
Correspondent Contact DARLENE M WELSH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/01/2006
Decision Date 09/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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