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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 K990256
Device Name CRX WORLD SHUNT
Applicant
PHOENIX BIOMEDICAL CORP.
2495 GENERAL ARMSTEAD AVE.
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
PHOENIX BIOMEDICAL CORP.
2495 GENERAL ARMSTEAD AVE.
NORRISTOWN,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received01/27/1999
Decision Date 04/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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