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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 K862907
Device Name P-S MEDICAL CSF-SIPHON CONTROL DEVICE
Applicant
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Applicant Contact STEPHEN W LAGUETTE
Correspondent
Pudenz-Schulte Medical Research Corp.
P.O. Box 2090
Goleta,  CA  93118
Correspondent Contact STEPHEN W LAGUETTE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/31/1986
Decision Date 12/03/1986
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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