GAMBRO MULTIPURPOSE SYSTEM MPS-10

System, Dialysate Delivery, Sealed

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Multipurpose System Mps-10.

Pre-market Notification Details

Device IDK881270
510k NumberK881270
Device Name:GAMBRO MULTIPURPOSE SYSTEM MPS-10
ClassificationSystem, Dialysate Delivery, Sealed
Applicant GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
ContactJeffrey Shideman,phd
CorrespondentJeffrey Shideman,phd
GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
Product CodeFII  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-24
Decision Date1988-08-24

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