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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 K981246
Device Name BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
Applicant
Integra Neurocare, LLC
8401 102nd St.
Suite 200-P.O. Box 390
Pleasant Prairie,  WI  53150
Applicant Contact LORI HAYS
Correspondent
Integra Neurocare, LLC
8401 102nd St.
Suite 200-P.O. Box 390
Pleasant Prairie,  WI  53150
Correspondent Contact LORI HAYS
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/06/1998
Decision Date 05/26/1999
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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