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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 K973525
Device Name MAURICE WORLDWIDE SHUNT SYSTEM
Applicant
Integra Neurocare, LLC
8401 102nd St.
Suite 200-P.O. Box 390
Pleasant Prairie,  WI  53150 -0390
Applicant Contact LORI L HAYS, MT (ASCP)
Correspondent
Integra Neurocare, LLC
8401 102nd St.
Suite 200-P.O. Box 390
Pleasant Prairie,  WI  53150 -0390
Correspondent Contact LORI L HAYS, MT (ASCP)
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/17/1997
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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