Bibag

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Bibag.

Pre-market Notification Details

Device IDK162716
510k NumberK162716
Device Name:Bibag
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 WINTER STREET Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 WINTER STREET Waltham,  MA  02451
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-29
Decision Date2017-05-18

Trademark Results [Bibag]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIBAG
BIBAG
77473835 4132148 Live/Registered
Fresenius Medical Care Holdings, Inc.
2008-05-14

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