PRISMAFLEX

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO RENAL PRODUCTS, INC.

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

Pre-market Notification Details

Device IDK110823
510k NumberK110823
Device Name:PRISMAFLEX
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
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 CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-24
Decision Date2011-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332414105266 K110823 000

Trademark Results [PRISMAFLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRISMAFLEX
PRISMAFLEX
78861703 not registered Dead/Abandoned
Gambro Lundia AB
2006-04-14
PRISMAFLEX
PRISMAFLEX
78859340 not registered Dead/Abandoned
Gambro Lundia AB
2006-04-11
PRISMAFLEX
PRISMAFLEX
78513902 3102098 Live/Registered
Gambro Lundia AB
2004-11-09
PRISMAFLEX
PRISMAFLEX
78272350 2979008 Live/Registered
Gambro Lundia AB
2003-07-09
PRISMAFLEX
PRISMAFLEX
76290339 not registered Dead/Abandoned
RIGIFLEX INTERNATIONAL
2001-07-26
PRISMAFLEX
PRISMAFLEX
76115953 2698334 Live/Registered
Prismaflex USA, Inc
2000-08-24

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