FDA.report

510(k) K090002

Device
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K090002
Product code
KPO  
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-07
Date received
2009-01-02
Regulation
876.5820
Classification name
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DONNA DJINOVICH
Address
1620 Waukegan Rd. Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

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50085412150616ACID CONCENTRATEBAXTER INTERNATIONAL INC.2015-10-24
50085412150593ACID CONCENTRATEBAXTER INTERNATIONAL INC.2015-10-24
50085412150586ACID CONCENTRATEBAXTER INTERNATIONAL INC.2015-10-24
50085412150579ACID CONCENTRATEBAXTER INTERNATIONAL INC.2015-10-24
50085412150562ACID CONCENTRATEBAXTER INTERNATIONAL INC.2015-10-24

Legacy Summary

summary

FDA Review

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