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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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