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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 K083542
Device Name FRESENIUS STERILE STAY SAFE CAP
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Applicant Contact JANET KAY
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Correspondent Contact JANET KAY
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received11/28/2008
Decision Date 12/29/2008
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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