BICARBOLYTE HEMO-DIAL

Accessories, Blood Circuit, Hemodialysis

EDLAW PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Edlaw Pharmaceuticals, Inc. with the FDA for Bicarbolyte Hemo-dial.

Pre-market Notification Details

Device IDK833896
510k NumberK833896
Device Name:BICARBOLYTE HEMO-DIAL
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant EDLAW PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-14
Decision Date1984-01-03

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