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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K022536
Device Name \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
Applicant
Fresenius Medical Care
95 Hayden Ave.
Lexington,  MA  02420
Applicant Contact ART EILINSFELD
Correspondent
Fresenius Medical Care
95 Hayden Ave.
Lexington,  MA  02420
Correspondent Contact ART EILINSFELD
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/01/2002
Decision Date 10/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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