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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K003445
Device Name FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Applicant Contact ARTHUR EILINSFELD
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5820
Classification Product Code
FIB  
Date Received11/06/2000
Decision Date 12/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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