BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE

The following data is part of a premarket notification filed by Fresenius Medical Care North America, Design Cente with the FDA for Bvm Hemodialysis Blood Tubing Set With Attached Priming Set And Transducer Protectors.

Pre-market Notification Details

Device IDK120823
510k NumberK120823
Device Name:BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 Winter Street Waltham,  MA  02451 -1457
ContactDenise Oppermann
CorrespondentDenise Oppermann
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 Winter Street Waltham,  MA  02451 -1457
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-19
Decision Date2012-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840861100474 K120823 000

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