EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE

Set, Administration, Intravascular

EXELINT INTL. CO.

The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel Huber Infusion Set With Needleless Injection Site.

Pre-market Notification Details

Device IDK012879
510k NumberK012879
Device Name:EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
ClassificationSet, Administration, Intravascular
Applicant EXELINT INTL. CO. 5840 WEST CENTINELA AVE. Los Angeles,  CA  90045
ContactArmand Hamid
CorrespondentArmand Hamid
EXELINT INTL. CO. 5840 WEST CENTINELA AVE. Los Angeles,  CA  90045
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-28
Decision Date2002-01-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10020221078593 K012879 000
10020221078418 K012879 000
10020221078449 K012879 000
10020221078456 K012879 000
10020221078463 K012879 000
10020221078487 K012879 000
10020221078494 K012879 000
10020221078500 K012879 000
10020221078548 K012879 000
10020221078555 K012879 000
10020221078562 K012879 000
10020221078586 K012879 000
10020221078401 K012879 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.