PRISMASATE

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

GAMBRO RENAL PRODUCTS

The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Prismasate.

Pre-market Notification Details

Device IDK013448
510k NumberK013448
Device Name:PRISMASATE
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant GAMBRO RENAL PRODUCTS 1845 MASON AVE. Daytona Beach,  FL  32117 -5102
ContactFei Law
CorrespondentFei Law
GAMBRO RENAL PRODUCTS 1845 MASON AVE. Daytona Beach,  FL  32117 -5102
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-17
Decision Date2002-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414108626 K013448 000
37332414108619 K013448 000
37332414108596 K013448 000
37332414108589 K013448 000
37332414108572 K013448 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

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