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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 K873247
Device Name CSF-FLOW CONTROL VALVE, ULTRA SMALL
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
928 GARDEN ST.
SANTA BARBARA,  CA  93101
Applicant Contact STEPHEN W LAQUETTE
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
928 GARDEN ST.
SANTA BARBARA,  CA  93101
Correspondent Contact STEPHEN W LAQUETTE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/14/1987
Decision Date 09/18/1987
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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