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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 K951258
Device Name PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
125 CREMONA DR.
GOLETA,  CA  93117
Applicant Contact TOM HOLDYCH
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
125 CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact TOM HOLDYCH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/21/1995
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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