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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 K042825
Device Name ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Applicant Contact DARLENE M WALSH
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08536
Correspondent Contact DARLENE M WALSH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received10/12/2004
Decision Date 12/21/2004
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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