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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 K960435
Device Name PHOENIX CRX VALVE
Applicant
Phoenix Biomedical Corp.
2495 General Armstead Ave.
P.O. Box 80390
Valley Forge,  PA  19484
Applicant Contact HORACE J WILMER
Correspondent
Phoenix Biomedical Corp.
2495 General Armstead Ave.
P.O. Box 80390
Valley Forge,  PA  19484
Correspondent Contact HORACE J WILMER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received01/31/1996
Decision Date 08/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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