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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 K121599
Device Name CRIT-LINE CLIP (CLIC)
Applicant
FRESENIUS MEDICAL CARE-NORTH AMERICA
920 Winter Street
Waltham,  MA  02451
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE-NORTH AMERICA
920 Winter Street
Waltham,  MA  02451
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5820
Classification Product Code
KOC  
Date Received06/01/2012
Decision Date 11/09/2012
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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