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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 K140722
Device Name INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
Applicant
INTEGRA LIFESCIENCES CORPORATION
22 TERRY AVENUE
BURLINGTON,  MA  01803
Applicant Contact JANET KAY
Correspondent
INTEGRA LIFESCIENCES CORPORATION
22 TERRY AVENUE
BURLINGTON,  MA  01803
Correspondent Contact JANET KAY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/21/2014
Decision Date 01/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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