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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 K024040
Device Name ACCURA ELITE SHUNT SYSTEM
Applicant
PHOENIX BIOMEDICAL CORP.
2495 GENERAL ARMISTEAD AVE.
P.O. BOX 80390
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
PHOENIX BIOMEDICAL CORP.
2495 GENERAL ARMISTEAD AVE.
P.O. BOX 80390
NORRISTOWN,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/06/2002
Decision Date 01/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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