MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

Apparatus, Hemoperfusion, Sorbent

GAMBRO RENAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Mars Monitor Itc Us, Mars Treatment Kit Type 1116/1 - X-mars Us, Prismaflex Control Unit.

Pre-market Notification Details

Device IDK133807
510k NumberK133807
Device Name:MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
ClassificationApparatus, Hemoperfusion, Sorbent
Applicant GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood,  CO  80401
ContactKae Miller
CorrespondentKae Miller
GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood,  CO  80401
Product CodeFLD  
CFR Regulation Number876.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-12-16
Decision Date2014-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37332414107728 K133807 000

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