EXEL VACUUM BLOOD COLLECTING SYSTEM

Needle, Hypodermic, Single Lumen

EXEL INTL.

The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Vacuum Blood Collecting System.

Pre-market Notification Details

Device IDK861152
510k NumberK861152
Device Name:EXEL VACUUM BLOOD COLLECTING SYSTEM
ClassificationNeedle, Hypodermic, Single Lumen
Applicant EXEL INTL. P.O. BOX 3194 Culver City,  CA  90231 -3194
ContactEshagh Hamid
CorrespondentEshagh 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 Received1986-03-26
Decision Date1986-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10020221765363 K861152 000
10020221265368 K861152 000
30020221265379 K861152 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.