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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
Device Name BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
Applicant
Fresenius Medical Care North America, Design Cente
920 Winter St.
Waltham,,  MA  02451 -1457
Applicant Contact DENISE OPPERMANN
Correspondent
Fresenius Medical Care North America, Design Cente
920 Winter St.
Waltham,,  MA  02451 -1457
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5820
Classification Product Code
FJK  
Date Received03/19/2012
Decision Date 06/15/2012
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
Predetermined Change
Control Plan Authorized		 No
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