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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K120823
Model 03-2795-7
Device Name BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
Original Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
920 winter street
waltham,  MA  02451 1457
Original Contact denise oppermann
Regulation Number876.5820
Classification Product Code
FJK  
Date Received03/21/2012
Decision Date 06/15/2012
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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