EXEL I.V. ADMINISTRATION SET

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 I.v. Administration Set.

Pre-market Notification Details

Device IDK010404
510k NumberK010404
Device Name:EXEL I.V. ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant EXELINT INTL. CO. P.O. BOX 3194 Culver City,  CA  90231 -3194
ContactArmand Hamid
CorrespondentArmand Hamid
EXELINT INTL. CO. P.O. BOX 3194 Culver City,  CA  90231 -3194
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-12
Decision Date2001-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10020221290889 K010404 000
10020221290865 K010404 000
00020221290851 K010404 000
10020221290834 K010404 000
00020221290820 K010404 000
10020221290810 K010404 000
10020221270867 K010404 000

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