TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET

Set, Administration, Intravascular

US INFUSION DBA TRUECARE BIOMEDIX

The following data is part of a premarket notification filed by Us Infusion Dba Truecare Biomedix with the FDA for Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set.

Pre-market Notification Details

Device IDK111351
510k NumberK111351
Device Name:TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
ClassificationSet, Administration, Intravascular
Applicant US INFUSION DBA TRUECARE BIOMEDIX 2003 NW 79TH AVE. Miami,  FL  33122
ContactAaron Compton
CorrespondentAaron Compton
US INFUSION DBA TRUECARE BIOMEDIX 2003 NW 79TH AVE. Miami,  FL  33122
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-13
Decision Date2011-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20850789007301 K111351 000
00860006128029 K111351 000
00850789007413 K111351 000
00850789007390 K111351 000
00850789007406 K111351 000
10850789007373 K111351 000
10850789007380 K111351 000
20850789007370 K111351 000
20850789007387 K111351 000
10850789007281 K111351 000
10850789007298 K111351 000
10850789007304 K111351 000
20850789007288 K111351 000
20850789007295 K111351 000
20850789007660 K111351 000

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