EXEL I.V. EXTENSION 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. Extension Set.

Pre-market Notification Details

Device IDK092172
510k NumberK092172
Device Name:EXEL I.V. EXTENSION SET
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 Received2009-07-21
Decision Date2010-01-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
01002022117307 K092172 000
10020221117209 K092172 000
10020221017721 K092172 000
10020221017301 K092172 000
00020221017205 K092172 000
10020221017127 K092172 000

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