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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 K972994
Device Name EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
Applicant
INTEGRA NEUROCARE LLC.
8401 102ND ST.
SUITE 200-P.O. BOX 390
PLEASANT PRAIRIE,  WI  53150 -0390
Applicant Contact LORI L HAYS
Correspondent
INTEGRA NEUROCARE LLC.
8401 102ND ST.
SUITE 200-P.O. BOX 390
PLEASANT PRAIRIE,  WI  53150 -0390
Correspondent Contact LORI L HAYS
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/12/1997
Decision Date 11/03/1997
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
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