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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
Recalls CDRH Recalls
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