PrismaSATE

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismasate.

Pre-market Notification Details

Device IDK162887
510k NumberK162887
Device Name:PrismaSATE
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant Baxter Healthcare Corporation 32650 North Wilson Road Round Lake,  IL  60073
ContactKristen Bozzelli
CorrespondentKristen Bozzelli
Baxter Healthcare Corporation 32650 North Wilson Road Round Lake,  IL  60073
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-17
Decision Date2017-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414123094 K162887 000

Trademark Results [PrismaSATE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRISMASATE
PRISMASATE
78032988 2670296 Live/Registered
GAMBRO RENAL PRODUCTS, INC.
2000-10-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.