B. BRAUN MODIFIED BICARBONATE DIALYSATE

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for B. Braun Modified Bicarbonate Dialysate.

Pre-market Notification Details

Device IDK052393
510k NumberK052393
Device Name:B. BRAUN MODIFIED BICARBONATE DIALYSATE
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactChristine Ford
CorrespondentChristine Ford
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-31
Decision Date2005-11-09
Summary:summary

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