ACCUSOL DIALYSIS SOLUTION

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Accusol Dialysis Solution.

Pre-market Notification Details

Device IDK041428
510k NumberK041428
Device Name:ACCUSOL DIALYSIS SOLUTION
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park,  IL  60085 -6730
ContactDavid E Curtin
CorrespondentDavid E Curtin
BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park,  IL  60085 -6730
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-28
Decision Date2004-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09349285000178 K041428 000
09349285000161 K041428 000
09349285000154 K041428 000

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