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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 K002476
Device Name LUMBOPERITONEAL SHUNT SYSTEM
Original Applicant
PHOENIX BIOMEDICAL CORP.
2495 general armistead ave.
p.o. box 80390
valley forge,  PA  19484
Original Contact courtney smith
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/11/2000
Decision Date 11/09/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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