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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 K033017
Device Name PHOENIX INFUSION CATHETER
Applicant
Phoenix Biomedical
P.O. Box 80390
2495 General Armistead Ave.
Valley Forge,  PA  19484
Applicant Contact COURTNEY SMITH
Correspondent
Phoenix Biomedical
P.O. Box 80390
2495 General Armistead Ave.
Valley Forge,  PA  19484
Correspondent Contact COURTNEY SMITH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/26/2003
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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