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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
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