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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K991520
Device Name FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02173
Applicant Contact ARTHUR EILINSFELD
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02173
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/03/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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