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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 K911410
Device Name PS MEDICAL BUTTON VALVE
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
P.O. BOX 2090
GOLETA,  CA  93118
Applicant Contact TOM HOLDYCH
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
P.O. BOX 2090
GOLETA,  CA  93118
Correspondent Contact TOM HOLDYCH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/01/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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