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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 K070222
Device Name FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Applicant Contact JANET C KAY
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Correspondent Contact JANET C KAY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/24/2007
Decision Date 04/24/2007
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
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