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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 K030468
Device Name ACURA ELITE GRAVITY COMPENSATING RESERVOIR
Applicant
Phoenix Biomedical Corp.
2495 General Armistead Ave.
P.O. Box 80390
Valley Forge,  PA  19484
Applicant Contact COURTNEY SMITH
Correspondent
Phoenix Biomedical Corp.
2495 General Armistead Ave.
P.O. Box 80390
Valley Forge,  PA  19484
Correspondent Contact COURTNEY SMITH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received02/12/2003
Decision Date 10/15/2003
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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