EXCEL PRIMARY SOLUTION 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 Excel Primary Solution Set.

Pre-market Notification Details

Device IDK031500
510k NumberK031500
Device Name:EXCEL PRIMARY SOLUTION 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 Received2003-05-13
Decision Date2003-07-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00020221270853 K031500 000
20020221260858 K031500 000

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