EXEL I.V. ADMINISTRATION SET

Set, Administration, Intravascular

EXEL INTL.

The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel I.v. Administration Set.

Pre-market Notification Details

Device IDK963659
510k NumberK963659
Device Name:EXEL I.V. ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant EXEL INTL. P.O. BOX 3194 Culver City,  CA  90231 -3194
ContactArmand Hamid
CorrespondentArmand Hamid
EXEL INTL. 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 Received1996-09-03
Decision Date1997-12-16

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