EXEL AVF SINGLE NEEDLE

Needle, Hypodermic, Single Lumen

EXEL INTL.

The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Avf Single Needle.

Pre-market Notification Details

Device IDK963658
510k NumberK963658
Device Name:EXEL AVF SINGLE NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
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 CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-03
Decision Date1998-05-05

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