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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intraventricular
510(k) Number K874498
Device Name CSF-VENTRICULOSTOMY RESERVOIR
Applicant
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Applicant Contact W LAGUETTE
Correspondent
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Correspondent Contact W LAGUETTE
Regulation Number882.5550
Classification Product Code
LKG  
Date Received11/02/1987
Decision Date 02/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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