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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K001873
Device Name HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02173
Applicant Contact ARTHUR ELLINSFELD
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02173
Correspondent Contact ARTHUR ELLINSFELD
Regulation Number876.5820
Classification Product Code
FJK  
Date Received06/20/2000
Decision Date 07/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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