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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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