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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, For Peritoneal Dialysis, Disposable
510(k) Number K022412
Device Name FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02420 -9192
Applicant Contact ARTHUR E EILINSFELD
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02420 -9192
Correspondent Contact ARTHUR E EILINSFELD
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received07/24/2002
Decision Date 03/05/2003
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
Recalls CDRH Recalls
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