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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
Model 4C3
Device Name CRIT-LINE CLIP (CLIC)
Original Applicant
FRESENIUS MEDICAL CARE-NORTH AMERICA
920 winter street
waltham,  MA  02451
Original Contact denise oppermann
Regulation Number876.5820
Classification Product Code
KOC  
Date Received06/01/2012
Decision Date 11/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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