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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 K913412
Device Name PS MEDICAL CSF-ACCESS DEVICE
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 Received07/31/1991
Decision Date 03/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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