PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

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 Dialysis Solutions For Continuous Renal Replacement Therapy.

Pre-market Notification Details

Device IDK072908
510k NumberK072908
Device Name:PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
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 Received2007-10-12
Decision Date2008-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412645822 K072908 000
37332414108602 K072908 000
37332414100170 K072908 000
37332414074648 K072908 000
37332414074013 K072908 000
37332414066834 K072908 000
37332414037049 K072908 000
37332414037032 K072908 000

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